CNS

iratezero

Bro thinks he can establish a mind muscle connection with his CNS

tandoori_taco_cat

> Try to feel your central nervous system Feeling your CNS with your CNS

HARCYB-throwaway

Try to feel your central nervous system when you are doing heavy lifts. Literally feel your spine. It activates your CNS much more strongly and you can push weight easier.

BarbellPadawan

Cool. Yeah I can get you some CNS depressants to combat the uppers or some stimulants to treat the downers. Or just a straightener if you need it. Whatever you want. We’ll figure it out and keep you safe. Also make sure it’s just a panic attack and not primary cardiopulmonary, just to be safe

Exciting-Whereas6935

Fair, they're not huge, but they also aren't tiny. Everyone has to start somewhere. Promising because they are addressing a major unmet need, treating CNS diseases is notoriously difficult due to the blood–brain barrier. Their strategy directly targets this challenge. A lot of companies don't even bother with this because it's so hard. A company that will succeed with this, will be very successful.

MediumSinger8088

Answering my own question... the standard of care for Gaucher's is enzyme replacement therapy, repeated injections every couple of weeks. For non-neuropathic Gaucher's you couldn't see a clear oral drug effect on top of the ERT and wouldn't get patients to forego the standard of care. Not enough market for neuropathic Gaucher's and if you're going to target CNS might as well go for PD.

MediumSinger8088

I would anticipate a partnership before outright acquisition. Cheaper for the big pharma partner, they can leverage with less money up front and impose milestones while maintaining first right of refusal to purchase at a later date. It manages risk more effectively. Best outcome IMO would be a partnership then premature termination of a Phase 2/3 clinical trial due to early achievement of primary endpoints. That would be very powerful but still take a while. The MICD for decline in a placebo arm relative to baseline would be 1-2 years. It just takes a long time to develop a drug, especially for a CNS indication.

Correct_Proposal_409

Phase 1 trials are to make sure that a drug is safe and shows target engagement. Phase 2 trials test efficacy in a controlled setting, and when phase 2 trials fail, it is usually because: * there is insufficient CNS exposure * the target turns out not to be central to the actual disease biology, * they don’t have the right patients. The drug may work for a particular subset of patients, but the trial has been diluted by too many patients who have a different disease biology. Parkinson’s Disease is often called Parkinson’s Disease**s** because there are multiple different points of initial failure which ultimately turns into Parkinson’s. Different genetic mutations, and some might start with lysosomal dysfunction, while others might start with mitochondrial dysfunction. Or maybe neuroinflammation. This is still being researched. * they are measuring the wrong endpoints, * they don’t have the timing right (i.e., trial not long enough to show efficacy, or the initial benefits don’t sustain for the length of the trial). * the biomarkers move, but they don’t translate to clinical benefits Gain’s 1b trial, along with the extension, gives them a lot of valuable information which goes a long way towards derisking the phase 2. Many phase 1 trials do not go nearly as far as Gain went since the 1b measured many biomarkers, along with clinical symptoms. This is unusual. The first major hurdle towards proving efficacy was reducing GluSph, since it is both a direct measure of lysosomal dysfunction and also a driver of further dysfunction and cellular stress. By reducing it in such a short time period (90 days) means not only that there was sufficient CNS exposure. It also strongly suggests that the lysosme has regained lost functionality and that the cellular stress burden has been reduced. And based on what we know about Gaucher’s disease, this GluSph reduction is a central marker for disease control, and the parallel lysosomal recovery is the key driver for disease-modification. So the most important biomarker for efficacy is already there. And the UPDRS score improvements that they’ve already released suddenly look more credible. We should know more about further scores and biomarkers shortly, but it follows that if GluSph was reduced so thoroughly in such a short time, other important biomarkers which take longer to affect should show signs of improvement even by 90 days, and if there is broad biomarker improvement, this reliably predicts clinical improvements since they are so well-correlated. The other big advantage of the data they know have is that they can use that to inform the phase 2 set-up. They’ve already narrowed the focus for their phase 2, tightening inclusionary and exclusionary criteria for enrolling patients, and they can further adjust as data comes in from the extension. Same with outcome measures. [Here is their current phase 2 registration](https://clinicaltrials.gov/study/NCT07280299?tab=table) (which can be updated). One inclusionary criteria that stands out is “Positive SAA in CSF at Baseline” and another exclusionary criteria is “PD-associated LRRK2 pathogenic variant or other PD-associated genetic mutations other than GBA1.”  They now know that GT-02287 is more likely to move the needle from a biomarker perspective by screening this way, so this increases the likelihood of success. So to answer your question, based on what we now know, I think the chances for success in phase 2 are high. And if we get more biomarkers (like Complex I, Miro1, aggregated a-Syn, NFL) that are beginning to show improvements, and if the UPDRS scores that are not worsening-- and I think Gain will show this data between the KOL and the AD/PD conference in March-- then I think the chances for phase 2 success will be extremely high.

MainDark3321

This run is related to their PPD drug that is nearing the end of it's phase 3 trial. Their press release in mid december announced they reached 80% enrollment and we'll get their 2nd DSMB safety update in mid January. If the enrollment pace continues at a similar rate they could be announcing complete enrollment in that same press release. The topline data is expected 2Q 2026, and as long as the data warrants it they'll be ready to file the NDA before the end of 2026. They have enough cash to get through the topline results and at least until Nov 2026 according to their last earnings report, but I don't think they have enough tonself fund the NDA. Whether they raise cash or find funding through a business development deal is unknown at this point. 1148 is an interesting asset, but their phase 2 had limited patiet population, I expect the FDA will require a phase 3 and more data. They have other interesting drugs in their pipeline for epilepsy, treatment resistant depression, and an adjunct therapy for glp-1's. Those drugs also need FDA input before the company can start phase 2 POV studies, and of course those aren't free so they'll need to prioritize how they're spending their cash. The point is, their lead CNS asset, LPCN 1154 aka Brlizio is nearing the end of its phase 3 trial. It's a faster acting (hours instead of days), shorter duration (48 hours vs 14 days) treatment than zurzuvae, which is the only oral ppd treatment currently on the market. Always do your own DD. If you find i'm wrong on any of this please post a correction, I'm just an amateur investor doing my best to share my understanding of what's happening with this company. Good luck with your investments.

Correct_Proposal_409

Very unfortunate market reaction to positive news which goes a long ways towards confirming that the drug is working. The PR was to conservative, and they are holding back additional data (possibly due to CDA with a pharma partner, or the are holding data for the KOL event and the AD/PD conference, not sure). Regarding the KOL event, it sounds like they will be reviewing additional data: “The event will also review biomarker results from the Phase 1b clinical study of GT-02287, demonstrating disease modifying potential in Parkinson’s disease patients with or without a GBA1 mutation.” I just wish they had put that as one of the top bullet points for the PR. I’m holding for buyout/partnership, which I think is more likely now. BTW, the BTIG analyst just came out with this note, and he agrees: “Readout Suggests GT-02287 is Activating GCase in the CNS. Additional Steps to Confirm it a PD Drug, but the Gain Approach Works. WHAT YOU SHOULD KNOW: We see the findings today serving as definitive evidence supporting GT-02287's ability to activate GCase in the brain. As a result, we see validation for the Gain approach and increased likelihood others will agree and look to partner other novel applications where allosteric modulation of enzyme deficiencies might benefit patients. The readout today measured the levels of GCase substrate, glucosylsphingosine (GluSph) in the CSF. The observed GluSph reductions in every patient that had elevated levels of this GCase substrate at trial start make it clear: GT-02287 increases the activity of its target enzyme. After 90 days of GT-02287 treatment, all individuals with elevated CSF GluSph experienced significant decreases.”

passionlessDrone

Inflammation is common in a ton of shit though; especially CNS shit. If inflammation was causing Parkinson's, we would have found evidence in the zillions of lifestyle studies or other things people have thrown at the wall.

optimalpooper

I don’t disagree that there should still be caution, cknowledging your point: everything important is still unproven • Many drugs in PD had great preclinical data and target engagement in humans (including venglustat, ambroxol, prasinezumab) and still failed to move clinical endpoints. • GT-02287 is only in Phase 1b; there is no randomized Phase 2/3 efficacy data yet. The field has a high failure rate, and mechanistic plausibility does not guarantee clinical success. Myself like many others is really bought into the science and not acknowledging some of the stark differences between what Gain is doing with their “mitochondria first” approach and the other mentioned is underrepresented in your analysis. No one in the current/previous Parkinson’s pipeline has really done exactly what Gain is doing (physics-heavy 3D platform tightly integrated with AI for discovery). I always have planned outs and have also been holding for quite some time. Anyone interested in the breakdown comparison can reference below. (Used AI to help simplify the summary): What’s potentially better about GT-02287’s science 1. Mechanism sits at a biologic “hub.” GCase deficiency links lipid metabolism, lysosomal stress, and α-syn accumulation. Fixing that one node could, in theory, influence multiple pathogenic processes at once. 2. Precision small-molecule design. GT-02287 isn’t a repurposed drug; it’s optimized for brain penetration, specific allosteric binding, and lysosomal function, based on 3D structural analysis of the protein (SEE-Tx®). 3. Broad applicability beyond GBA1-mutant PD. Because GCase activity is also reduced in idiopathic PD, Gain is deliberately studying with and without GBA1 mutations, which could widen the addressable patient pool if efficacy is shown. 4. Strong biomarker plan. The Phase 1b study is not just “does the drug look safe.” They’re explicitly measuring GCase modulation and substrate changes in CSF/plasma, which should give a clean read on whether the biology works in humans, even before larger efficacy trials. How GT-02287 is different from Venglustat: • Fixing the enzyme vs. turning down the faucet. • Venglustat: Tries to help by reducing substrate load but doesn’t correct misfolded GCase or restore its normal lysosomal function. • GT-02287: Directly stabilizes GCase and improves its trafficking and activity in lysosomes, aiming to normalize the enzyme itself. How GT-02287 is different from Ambroxol: • Rational design vs. repurposed drug. • Ambroxol was never designed for the brain or for PD; it has other pharmacology (e.g., effects on ion channels) and needs high doses to get robust CNS effects.  • GT-02287 was discovered with Gain’s SEE-Tx® computational platform to bind a specific allosteric pocket on GCase and is optimized for CNS penetration and GCase modulation.  • Allosteric STAR vs. mixed-mechanism chaperone. Ambroxol is essentially a “happy accident” GCase chaperone; GT-02287 is a Structurally Targeted Allosteric Regulator with a clearly mapped pocket and structure-activity relationship. • Program built around biomarkers from day 1. GT-02287’s Phase 1b trial is explicitly built around CSF and plasma biomarkers (GCase activity, lipid substrates, PD-adjacent markers) as key secondary endpoints, on top of safety.  How GT-02287 is different Prasinezumab (Roche/Prothena)/Cinpanemab (Biogen): • Upstream lysosome repair vs. downstream aggregate mopping. • mAbs are dealing with extracellular or interstitial α-syn; they do little for the intracellular lysosomal/ER stress and protein degradation defects that likely drive disease. • GT-02287 aims to repair lysosomal function at the enzyme level, indirectly reducing α-syn burden by making the cell’s own disposal system work better. 

jubilantBeatbox

**Future Outlook** * **Catalysts**: * **Upcoming earnings report**: Expected **November 13, 2025** \[CNBC\]. * **CNS Summit 2025 (October 2025)**: Presentation of negative symptom data from Phase 3 RECOVER trial. * **FDA alignment**: Gained in April 2024 for Phase 3 program in schizophrenia \[Simply Wall St\]. * **Potential Phase 3 confirmation trial** may be required for FDA approval. * **Forecast**: Expected to **breakeven in 2026**, though this depends on successful financing and trial outcomes \[Simply Wall St\]. The **clinical pipeline is promising**, but **financial sustainability remains the biggest challenge**. **Competitor Comparison** All are small-cap biotechs, but Reviva’s **focus on broad-spectrum CNS and respiratory applications** differentiates it. However, **Cerevel** represents a more mature comparator with deeper resources.

jubilantBeatbox

Here are the results: tables removed to fit here. NFA, AI generated content: **Business Overview** Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) is a **late-stage clinical biopharmaceutical company** headquartered in Cupertino, California, focused on discovering, developing, and commercializing next-generation therapeutics for diseases with **unmet medical needs** in the areas of **central nervous system (CNS), respiratory, inflammatory, and cardiometabolic diseases**. The company's lead product candidate is **brilaroxazine (RP5063)**, a multimodal neuromodulator currently in advanced clinical development. Brilaroxazine is being evaluated primarily for **schizophrenia**, with additional potential indications including **bipolar disorder, major depressive disorder (MDD), attention-deficit/hyperactivity disorder (ADHD), behavioral and psychotic symptoms of dementia and Alzheimer’s disease, and Parkinson’s disease psychosis**. Positive topline data from the **Phase 3 RECOVER trial** in schizophrenia was announced in October 2024, with sustained efficacy and a favorable safety profile observed in the open-label extension (OLE) study over 1 year. In addition, brilaroxazine is ready for clinical development in **pulmonary arterial hypertension (PAH)** and **idiopathic pulmonary fibrosis (IPF)**, and the company is developing **RP1208**, a triple reuptake inhibitor (TRI), for **depression and obesity**. Reviva’s business model centers on **internal drug discovery using proprietary chemical genomics platforms**, aiming to accelerate development while maintaining high safety and efficacy standards. The company was founded in 2018 and operates with a lean team, focusing on strategic clinical advancement and regulatory alignment. **Corporate & Regulatory Risks** **Adverse News & Regulatory Risks** * **Financial Position Risk**: Simply Wall St flagged a "New major risk - Financial position" on **November 16, 2025**, citing insufficient cash runway and negative shareholders' equity. A similar warning was issued on **August 15, 2025** \[Simply Wall St, 2025-07-24\]. * **Shareholder Dilution Risk**: A "New major risk - Shareholder dilution" was noted on **January 23, 2025**, due to repeated follow-on equity offerings \[Simply Wall St\]. * **Negative Shareholders' Equity**: A major risk of **negative shareholders' equity** was flagged on **November 17, 2024** \[Simply Wall St\]. * **Delayed Filings**: Reviva announced delayed annual 10-K filings on **April 1, 2025**, and **April 3, 2024**, raising concerns about corporate governance and transparency \[Simply Wall St\]. * **NASDAQ Compliance**: The company received a notice of **regained compliance** with Nasdaq’s minimum market value listing requirement on **October 18, 2025**, following a prior deficiency \[Simply Wall St\].

Correct_Proposal_409

It sounds like Gain will fit this small list since, based on a previous statement, they will be measuring in the CNS: α-synuclein (total, aggregated, and phosphorylated). Regarding your last statement on wanting to see an increase in the CSF, it I'm reading that (paraphrased from AI) increased a-synuclein in the CSF happens with extracellular treatments like monoclonal antibodies, whereas GT-02287 restores function inside the lysosome where misfolded a-synuclein is degraded and not exported into the CSF, so there should be a reduction in "pathogenic or seed-competent a-synuclein species" in the CSF.

Emotional_Doctor_140

Plus Therapeutics Secures National Coverage Agreement with Humana for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer

BiologicalUnit

Great news for PSTV $PSTV Plus Therapeutics Secures National Coverage Agreement with Humana for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer https://www.stocktitan.net/news/PSTV/plus-therapeutics-secures-national-coverage-agreement-with-humana-iu6giw4somvi.html

Correct_Proposal_409

https://preview.redd.it/liydunxc5f1g1.jpeg?width=1284&format=pjpg&auto=webp&s=362b3c2f535995f3532c48efbe6ef92200e357a0 You’re right that dilution is common in biotech, and it in fact has been happening some via Gain’s ATM recently — but in Gain’s case it’s looking less and less likely that there will be a large, go-it-alone cash raise for P2. Gain has been in active discussions with a handful of mid- and large-cap pharmas for at least the last year, probably longer. Management has made it clear they do not want to run Phase 2 or Phase 3 alone, and these potential partners have already completed nearly all of their due diligence. At this point, the only missing piece is the biomarker data… and realistically, these companies either already have early access to it or will see it next week at Neuroscience behind closed doors. GT-02287 went into Phase 1b already mostly de-risked, with: • strong mechanistic clarity (ER → lysosome → mitochondrial rescue) • 53% GCase activity increase in healthy humans • full motor rescue in multiple animal models • dose-dependent reversal of α-syn and toxic lipids • safety and CNS penetration already proven The upcoming biomarker readout is essentially the final confirmation… no meaningful downside risk and enormous upside potential. Even (what I believe is) the base-case scenario (highly effective in GBA1 patients) is a multibillion-dollar market. Big pharma clearly does not necessarily wait for P2 anymore (see slide). If you’re Merck, AbbVie, Lilly, or Roche… why would you risk letting the first disease-modifying Parkinson’s drug in history slip to a competitor? Especially when: • 90%+ of PD patients have lysosomal / GCase pathway dysfunction • Early signals already include improved smell and balance — the rarest and strongest markers of disease modification • Gain’s market cap is \~$100M I this is exactly the point in development where large pharma steps in: after the biology is validated but before the price goes up 10×. Dilution is possible— but a partnership or acquisition is far more likely, and far more rational, given the competitive landscape and what’s at stake. Btw, they still have a significant amount of their ATM available, which they’ve been using strategically to add runway space.

MediumSinger8088

Ambroxol is apparently a mucolytic that stimulates lung surfactant production and physically interacts with components of mucus - I admit I wasn't familiar with it. The structure doesn't look very CNS-penetrating, and PK would be fast, due to glutathione conjugation at those bromine centers. It may have tangential effects on lysosomes or autophagy but likely not direct effects based on engagement with specific proteins which major investors want. IMO chief competition / synergies of 02287 are LRKK2 inhibitors being developed by Neuron23 (private) and Sanofi. GCase and LRKK2 pathways converge at the lysosome or autophagolysosome (mitochondrial digestion) so these are complementary drugs.

Correct_Proposal_409

Yes, it has had underwhelming success to say the least. For whatever reason, it does not seam to increase Gcase activity consistently or impressively in the CNS (where it counts). In some trials, Gcase went down in the CNS. Preclinical work showed a little lysosomal clearing, but nothing like GT-02287, and no reduction of ER stress, improved mitochondrial function, reduced neuroinflammation like 2287 showed. Basically, not even considered competition.

budoobudoo

You are probably not wrong. Just not right enough. If we're talking pure alpha in the metabolic disease game, let's zoom east to Hong Kong where the real fireworks are popping off. I'm eyeing Innogen-B (02591.HK) and PegBio (02565.HK) as straight-up superior moonshots right now, all laser-focused on the GLP-1 revolution that's exploding in Asia's massive diabetes and obesity market. These aren't diluted plays like UNH's insurance sprawl or HOOD's trading volatility; they're razor-sharp biotechs riding China's 1.4 billion-person wave, with approvals incoming and valuations that make US counterparts look like overpriced lattes. Let me break down why swapping some of that bag for these HK gems could 5x your portfolio by 2028—pure fire, no fluff. First off, the macro setup in Hong Kong biotech is straight dominance mode. While the US Nasdaq biotech index is grinding up a measly 20% this year, Hong Kong's Hang Seng Biotech Index has ripped 80%+, outrunning even AI hype. Why? Beijing's pumping state cash into "Made in China 2025" for pharma independence, with 14 fresh listings already raising over HK$18 billion in 2025—quadrupling last year's haul—and 36 more queued up. Valuations? HK biotechs trade at 8-10x forward sales on average, versus 18x+ for US peers, giving you dirt-cheap entry into 30%+ CAGR growth as Asia's diabetes epidemic (hello, 140 million cases and counting) meets ultra-long-acting GLP-1s that crush Ozempic's dosing hassle. No DOJ probes or Medicare cuts here—just streamlined NMPA nods and export pipelines to Southeast Asia. HIMS is cute with its telehealth subs, but it's a US middleman facing Amazon's boot; these HK plays own the IP and manufacturing in the world's fastest-scaling market. Take Innogen-B: This beast just exploded 296% on debut in August, opening at HK$72 after pricing at HK$18.68, and it's still humming around HK$50-60 with HK$683 million fresh in the tank from an IPO oversubscribed 5,365 times—HK$370 billion in bids from 260k investors, second-hottest in Hong Kong this year. Their crown jewel, Efsubaglutide Alfa (branded Diabegone), is Asia's first homegrown humanized long-acting GLP-1 agonist, already greenlit for type 2 diabetes in China and barreling through late-stage trials for obesity and MASH (that fatty liver goldmine worth $30 billion globally). Early data? 7% weight drop in four weeks, with monthly dosing that laps weekly shots—perfect for compliance in a market where 80% of patients ghost treatments. They're deploying IPO cash for Phase III global pushes, commercial ramps, and CNS add-ons, turning red ink (losses narrowed to HK$175 million last year) into black by mid-2026. Compared to HIMS' 50x P/E bloat and GLP-1 supply glut risks, Innogen's at <5x sales with zero revenue yet—pure asymmetry. Bears whine about Eli Lilly/Novo competition, but Innogen's local pricing edge (half the cost) and China-first moat mean they snag 10-15% market share easy, printing HK$10 billion revenue by 2030. UNH? It's a sleepy dividend cow at 13x earnings, dodging cyber headaches but capped at 8-10% growth; Innogen's your uncapped rocket to HK$300/share. Then PegBio seals the deal as the stealth assassin. Listed earlier this year at HK$15.60, raising HK$301 million for a HK$6 billion val, it dipped to HK$10 on open but clawed back to HK$15+ on pipeline heat—up 7% monthly despite broader volatility. Their lead, PB-119, is another long-acting GLP-1 banger for diabetes and obesity, with NMPA acceptance last year and marketing greenlight eyed for Q1 2026. Preclinicals on PB-2301 (GLP-1/GIP dual) and PB-2309 (triple agonist) target NASH and rare endocrines, diversifying beyond HIMS' one-trick pony. R&D burn was HK$280 million in 2022, tapering to HK$76 million YTD as trials wrap, with cash at HK$27 million pre-IPO now beefed for launch and expansions. Losses ticked up slightly to HK$283 million last year on zero revenue, but that's biotech math—post-approval, ARPU from chronic scripts hits HK$500/year per patient in a 500 million obese Asian pool. Versus HOOD's cyclical 70% transaction reliance (hello, 35% revenue crater in '22), PegBio's recurring revenue moat is ironclad, with PEGylation tech for custom peptides adding service upside. Analysts are mum on ratings yet, but the sector tailwind screams Buy; at 4x projected sales, it's a steal next to UNH's regulatory quicksand (DOJ antitrust, 85% loss ratios). PegBio could 4x to HK$60 by 2027 if PB-119 captures 5% China share, while HOOD prays for bull markets. Bottom line, apes: HIMS/HOOD/UNH are fine for balanced bags, but Innogen and PegBio are the asymmetric edges—cheaper entries, explosive China growth (20% GDP healthcare slice by 2030), and GLP-1 purity without US baggage. HK's policy rocket fuel means 50-100% pops on approvals alone, while US names grind through comps and comps. I'm allocating 20% here; dips under HK$45 for Innogen and HK$12 for PegBio are no-brainers. DYOR, markets flip fast, but this is where the smart money's flowing east. Who's jumping in? 🚀🇭🇰 #HKBiotech #GLP1Bets

ImaginationRoutine96

You’re framing this like Gain is clueless about whether the drug gets into the brain, but that shows you haven’t actually looked at the data. They already measured CNS penetration in humans in the Phase 1 MAD cohort. It’s right there in the deck. Healthy volunteers showed clear CSF exposure of GT-02287 — 3.1 ng/mL on average, which matches the levels that worked in rodent models. The rodents actually had 2–8x higher drug levels in actual brain tissue than plasma, which is exactly what you want for a CNS drug. So no, they’re NOT “waiting to find out” if it crosses the BBB. They already know it does. The upcoming readout isn’t about basic penetration; it’s about confirming that long-term dosing in Parkinson’s patients produces consistent CNS levels and that those levels tie into: GCase activation, lysosomal + mitochondrial restoration, sphingolipid reduction and alpha-synuclein-related biomarkers On top of that, they’ve already shown functional improvement by Day 90 in the Phase 1b group. That alone sets them apart from pretty much every symptomatic PD treatment and most early “disease-modifying” attempts. And yes, other companies are working on Parkinson’s. That’s not the point. AskBio’s gene therapy is a totally different approach which is invasive, risky, and expensive. GT-02287 is an oral small molecule that restores GCase function across the entire disease cascade. If you actually compare mechanisms, they aren’t even in the same category. So the idea that Gain is behind or “doesn’t know” whether the drug hits the brain is just wrong. They already proved CNS exposure. What they’re about to share is the translation whether that CNS exposure, in actual PD patients, lines up with biomarkers and functional benefit. That’s the data big pharma waits for before writing a check.

Paroxysm777

RVPH news too Recent RVPH News Highlights European Patent Granted: Reviva announced on November 10, 2025, the grant of a European patent covering the use of its lead drug, brilaroxazine, for the treatment of pulmonary fibrosis. Conference Participation: The company is scheduled to participate in several investor conferences, including the Spartan Capital Securities Second Annual Investor Conference and the CNS Summit 2025 in November 2025. Clinical Trial Data Presentation: Reviva plans to present data for brilaroxazine in schizophrenia from its Phase 3 RECOVER trials at the CNS Summit 2025. Stock Performance and Offerings: The stock has been volatile, with a significant decline over the past year, and the company has executed several public offerings to raise capital in 2025. This dilution has been a point of discussion among investors. FDA Discussions: A key upcoming event is the U.S. FDA's decision in late 2025/early 2026 on whether Reviva needs to conduct a second Phase 3 trial for brilaroxazine before submitting a New Drug Application (NDA) for schizophrenia treatment.

ImaginationRoutine96

That’s a fair take, but it misses what Gain Therapeutics is actually signaling with their capital structure and trial design. They aren’t trying to fund a Phase 2 or 3 internally, that’s intentional. The company strategically left enough cash runway to complete their biomarker data readout and advance the asset to a Phase 2 ready stage, because that’s the inflection point where strategic partnerships or outright acquisition deals usually happen in biotech. Management has been clear that their goal is not to dilute shareholders to fund a multi year, multimillion dollar Phase 2 or 3. Instead, they’re positioning GT-02287 to be de-risked, showing both safety and early efficacy signals, right before larger pharma steps in. This is the same approach used in many CNS and rare disease deals where early proof of mechanism drives billion dollar valuations, like we’ve seen with Denali, Cerevel, and Neurocrine. As for competition, yes, others are in the race, but GANX has shown actual functional improvement, including patients regaining sense of smell, reduced tremors, and improved balance. Those outcomes are something no other Parkinson’s therapy has achieved so far. They point to disease modification, not just symptom relief. If the upcoming biomarker data confirms blood brain barrier penetration and reduction of alpha synuclein, they’ll have something the rest of the field doesn’t, real proof of disease modifying effect in humans. So the low insider buying narrative misses the bigger picture. Management isn’t betting on long term internal development, they’re betting on a near term strategic transaction once the data validates the science.

Orange_Codex

The company [website](https://revivapharma.com/reviva-to-present-negative-symptom-data-for-brilaroxazine-in-schizophrenia-from-the-phase-3-recover-double-blind-and-open-label-extension-trials-at-the-cns-summit-2025): >Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that negative symptom data for brilaroxazine from the Phase 3 RECOVER double-blind trial in patients with acute exacerbation of schizophrenia, and from the long-term open-label extension trial in clinically stable schizophrenia patients will be presented as a poster presentation at the CNS Summit 2025, taking place November 2-5, in Boston, Massachusetts.

Splendid_muralist

Is it not true that RVPH is presenting both at the SPARTAN INVESTOR CAPITAL CONFERENCE in NEE YORK CITY on NOV 3rds/2025 - as well as at the CNS SUMMIT in BOSTON MASSACHUSETTS from NOV 2-5th? This could be a monumental week for RVPH - and begin to funnel it full of hype for all of NOVEMBER - through to leading up to the hopeful FDA meeting in MID DECEMBER - This could finally be the time RVPH becomes the front runner for crazy climbing and growth - 🚀 This process range now is the very lowest you will be able to enter into - Let’s hope RVPH gets the attention it deserves and skyrockets in the weeks and months to come!

kenikh

I’m going to push back on the framing in this post, not because the drug isn’t promising, but because it glosses over the real risks that will determine outcomes here. Let’s start with what’s real: brilaroxazine has delivered strong Phase 3 data. The RECOVER-1 trial hit its primary endpoint with a 10.1-point PANSS reduction versus placebo (p<0.001). More importantly, 159 patients completed a full year in the open-label extension with an 18.1-point mean PANSS reduction and only 35% discontinuation rate. That’s meaningfully better safety tolerability than existing antipsychotics show in comparable studies. The Phase 2 REFRESH data was also positive and the FDA apparently flagged interest in a potential “superior safety” label claim. This isn’t a situation where the company is hoping for data that doesn’t exist yet. So on pure efficacy and safety, the drug profile is legitimately competitive. Where the Bull Case Breaks Down: Regulatory Precedent. Here’s where it gets sloppy. The FDA typically requires two adequate and well-controlled trials for schizophrenia approvals. This isn’t a guideline; it’s the standard. Minerva Neurosciences just got rejected in February 2024 with Phase 2 data, an open-label extension, and positive preliminary Phase 3 signals. The FDA explicitly told them the single positive trial wasn’t enough. Cobenfy (KarXT) got approved in September 2024, but it had two completed Phase 3 trials demonstrating efficacy. RVPH has one Phase 3 trial. Yes, they have Phase 2 data supporting it and strong OLE data, but Minerva had similar argument strength and got rejected. The December End-of-Phase-3 meeting will determine whether the FDA waives the two-trial requirement. The company seems to be betting they will. But betting the FDA will treat you differently than Minerva got treated is not a high-probability wager. Realistic probability the FDA says “your single Phase 3 is sufficient, submit your NDA”: 35-45%. Not zero, but not obvious. The company has approximately $10.4M in cash as of Q2 2025. Quarterly burn is 6-8 million. That’s roughly 1 to 1.5 quarters of runway from the date that post was written. They just did a 10 million offering at 0.50 per share in September. That bought them maybe another quarter. We’re now in early November and they’re still burning 6-8 million per quarter. By Q2 2026, when they’re targeting NDA submission, they will need to have raised additional capital. Almost certainly a lot of it. Any capital raise at 0.60 per share is going to absolutely crater shareholder value. Here’s the kicker: if the December FDA meeting goes sideways and they need to run RECOVER-2, they’re looking at 30-50 million in additional cash needs. At current valuations, that’s a reverse split followed by a brutal dilution event. Dilution: The December 18 annual meeting agenda includes a reverse stock split proposal (1:2 to 1:20 range). That’s a NASDAQ compliance flag. The company is already signaling financial stress. Anyone buying at 0.60 needs to model scenarios where the share count increases 50-100% in the next 18 months to fund operations. The upside targets analysts are quoting (2.00 to 16.00) were set before the latest dilution wave and assume either: (a) no RECOVER-2 required, or (b) easy capital raise at reasonable valuations. Neither is happening. H.C. Wainwright cut their target from 11.00 to 4.00 in October. Benchmark cut from 14.00 to 7.00 in September. Both cited dilution and financing concerns. That’s not market noise; that’s analysts repricing for execution risk. What Could Actually Happen: - Scenario 1 (30-40% probability): December FDA meeting says yes, RECOVER-1 plus Phase 2 data is sufficient. NDA submission Q2 2026, potential approval Q1-Q2 2027. Stock goes higher on the meeting, but faces additional dilution before that. Net upside from current levels: 3-5x if approved, but heavily diluted. - Scenario 2 (50-60% probability): FDA requires RECOVER-2. Program extends to late 2027 minimum. Major capital raise required immediately. Dilution is severe. Stock trades sideways or lower until real data de-risks the path. Net return: probably negative from current levels until approval. - Scenario 3 (10% probability): FDA wants additional studies beyond RECOVER-2. Program gets pushed back years. Capital needs balloon. Stock becomes a zero. Catalysts: The CNS Summit and Spartan Capital presentations this week are real, but understand what they are: investor visibility plays. The actual decision point is the December FDA meeting. That’s the binary event. If Reviva comes out and says “FDA agreed RECOVER-1 data is sufficient, we’re submitting NDA in Q2 2026,” the stock rips. If they say “FDA wants RECOVER-2, we’re refocusing capital on that,” the stock probably falls 30-50%. Underrated? On current valuations with strong clinical yes, there’s optionality here. But “underrated” assumes the company survives to prove the drug works. The financial situation makes that assumption risky. For a sophisticated trader: a small position sized for binary risk on the December outcome makes sense. The risk/reward on the upside is real if the FDA decides to be permissive. For retail hoping to hold through approval: understand you’re buying a company with less than 2 quarters of cash runway and massive dilution ahead. The drug might work, but the equity could get destroyed anyway. The clinical thesis is legit. The regulatory path is uncertain. The financial situation is precarious. That’s a more honest read than “criminally underrated” gets you.

IckyStickyToeNails

Ticker: $RVPH (NASDAQ) Sector: Biotech / CNS Drugs Reviva Pharmaceuticals is a small-cap biotech developing Brilaroxazine (RP5063), a potential treatment for schizophrenia and bipolar disorder. It’s a clinical-stage company, so no major revenue yet — but sentiment and short positioning are what make it interesting right now. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56–$0.58, and a breakout above that level could target $0.65–$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%–112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1–2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA. Current price sits around $0.6375, flat on light volume but holding firm above VWAP ($0.58) and SMMA 7 ($0.63). That means buyers are still in control — no selloff, just a healthy sideways base forming under resistance. RSI cooled to 64 from earlier overbought levels (~79), which resets momentum and leaves room for another move up. This is exactly what you want to see after a breakout — consolidation near the highs instead of a full retrace. Key levels: Support: $0.60–$0.62 zone, VWAP $0.58 must hold. Resistance: $0.67–$0.70 remains the breakout level to watch. Next targets: $0.75 and $0.80+ if volume returns and shorts start covering. Summary: RVPH is cooling off after a strong run, building strength above VWAP. As long as it stays over $0.60, the setup remains bullish and ready for another test of the $0.67–$0.70 zone.

AntidoteAlt

Im not doing more reasearch on a microcap with this high of dilution risk. Best-in-clasa require three things: efficiency, safety/tolerability, and marker access. And market access is huge, it dosent matter how good it is, market access is everything. Cobenfy is actively locking down payer coverage and prescriber familiarity, they will have multiple years of real-world data and marketing muscle by the time RVPH even gets an FDA decision. That creates incumbency prestige. RVPH can’t afford to prove superiority Clinically, they have angles that look best-in-class on paper, but cmc is a complete mess. They’re claiming coverage of positive symptoms, negative symptoms, cognitive function, functional outcomes, claiming cleaner safety, once-daily dosing, they're teasing an anti-neuroinflammation mechanism other drugs don’t have. They're doing alot and it looks great But You cannot be best in class in a mass-market CNS indication without money because “best in class” isn't just biology, it’s market capture. RVPH is structurally priced out of the heavyweight division. If they partner, now you’ve solved money, but you also just sold away most of your economic upside, and the partner will position you however it benefits their broader psych portfolio. And it's not up to me to make sure my datas up to date, i specifically disclosed it was over a month old. If you would like to provide an actual thesis on your opinion go ahead. But you just started posting about stocks 24 hours ago and you're only talking about RVPH, so i doubt you have any idea what you're actually doing. Please reconsider, you're gonna lose all your money if you keep up (mabey not on this play, but keep doing your level of conviction building and it wont be long before you're there)

IckyStickyToeNails

Ticker: $RVPH (NASDAQ) Sector: Biotech / CNS Drugs Reviva Pharmaceuticals is a small-cap biotech developing Brilaroxazine (RP5063), a potential treatment for schizophrenia and bipolar disorder. It’s a clinical-stage company, so no major revenue yet — but sentiment and short positioning are what make it interesting right now. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56–$0.58, and a breakout above that level could target $0.65–$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%–112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1–2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA. Current price sits around $0.6375, flat on light volume but holding firm above VWAP ($0.58) and SMMA 7 ($0.63). That means buyers are still in control — no selloff, just a healthy sideways base forming under resistance. RSI cooled to 64 from earlier overbought levels (~79), which resets momentum and leaves room for another move up. This is exactly what you want to see after a breakout — consolidation near the highs instead of a full retrace. Key levels: Support: $0.60–$0.62 zone, VWAP $0.58 must hold. Resistance: $0.67–$0.70 remains the breakout level to watch. Next targets: $0.75 and $0.80+ if volume returns and shorts start covering. Summary: RVPH is cooling off after a strong run, building strength above VWAP. As long as it stays over $0.60, the setup remains bullish and ready for another test of the $0.67–$0.70 zone.

IckyStickyToeNails

Ticker: $RVPH (NASDAQ) Sector: Biotech / CNS Drugs Reviva Pharmaceuticals is a small-cap biotech developing Brilaroxazine (RP5063), a potential treatment for schizophrenia and bipolar disorder. It’s a clinical-stage company, so no major revenue yet — but sentiment and short positioning are what make it interesting right now. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56–$0.58, and a breakout above that level could target $0.65–$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%–112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1–2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all good Current price sits around $0.6375, flat on light volume but holding firm above VWAP ($0.58) and SMMA 7 ($0.63). That means buyers are still in control — no selloff, just a healthy sideways base forming under resistance. RSI cooled to 64 from earlier overbought levels (~79), which resets momentum and leaves room for another move up. This is exactly what you want to see after a breakout — consolidation near the highs instead of a full retrace. Key levels: Support: $0.60–$0.62 zone, VWAP $0.58 must hold. Resistance: $0.67–$0.70 remains the breakout level to watch. Next targets: $0.75 and $0.80+ if volume returns and shorts start covering. Summary: RVPH is cooling off after a strong run, building strength above VWAP. As long as it stays over $0.60, the setup remains bullish and ready for another test of the $0.67–$0.70 zone.

IckyStickyToeNails

Buy Ticker: $RVPH (NASDAQ) Sector: Biotech / CNS Drugs Reviva Pharmaceuticals is a small-cap biotech developing Brilaroxazine (RP5063), a potential treatment for schizophrenia and bipolar disorder. It’s a clinical-stage company, so no major revenue yet — but sentiment and short positioning are what make it interesting right now. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56–$0.58, and a breakout above that level could target $0.65–$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%–112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1–2 days Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to cThe stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56-$0.58, and a breakout above that level could target $0.65-$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%-112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1-2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all gooThe stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56-$0.58, and a breakout above that level could target $0.65-$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%-112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1-2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56-$0.58, and a breakout above that level could target $0.65-$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%-112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1-2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all good Short-Term (next 1–2 days): $0.67–$0.70: First resistance zone — expect profit-taking here. $0.75: Secondary breakout target if volume stays high. $0.80–$0.85: Stretch move — would need strong buying or short covering. Medium-Term (if squeeze continues or catalyst hits): $1.00: Major psychological level — likely where shorts start to cover more aggressively. $1.20–$1.50: Full squeeze potential zone if borrow fees remain elevated and volume spikes. $2.00+: Long-shot catalyst target — would require major positive trial or FDA-related news. Key supports: $0.58 (VWAP area) — needs to hold to keep momentum alive. $0.52–$0.55 — base support zone from earlier breakout. Summary: If $RVPH holds above $0.58 and breaks through $0.67–$0.70, the next short-term push could target $0.75+. Below $0.58, momentum fades and a pullback toward $0.52–$0.55 is likely. This combination — high short interest, rising borrow fee, and no availability — signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward.

IckyStickyToeNails

Ticker: $RVPH (NASDAQ) Sector: Biotech / CNS Drugs Reviva Pharmaceuticals is a small-cap biotech developing Brilaroxazine (RP5063), a potential treatment for schizophrenia and bipolar disorder. It’s a clinical-stage company, so no major revenue yet — but sentiment and short positioning are what make it interesting right now. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56–$0.58, and a breakout above that level could target $0.65–$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%–112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1–2 days Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all good signals. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56-$0.58, and a breakout above that level could target $0.65-$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%-112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1-2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all good Short-Term (next 1–2 days): $0.67–$0.70: First resistance zone — expect profit-taking here. $0.75: Secondary breakout target if volume stays high. $0.80–$0.85: Stretch move — would need strong buying or short covering. Medium-Term (if squeeze continues or catalyst hits): $1.00: Major psychological level — likely where shorts start to cover more aggressively. $1.20–$1.50: Full squeeze potential zone if borrow fees remain elevated and volume spikes. $2.00+: Long-shot catalyst target — would require major positive trial or FDA-related news. Key supports: $0.58 (VWAP area) — needs to hold to keep momentum alive. $0.52–$0.55 — base support zone from earlier breakout. If $RVPH holds above $0.58 and breaks through $0.67–$0.70, the next short-term push could target $0.75+. Below $0.58, momentum fades and a pullback toward $0.52–$0.55 is likely. This combination — high short interest, rising borrow fee, and no availability — signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward.

IckyStickyToeNails

Ticker: $RVPH (NASDAQ) Sector: Biotech / CNS Drugs Reviva Pharmaceuticals is a small-cap biotech developing Brilaroxazine (RP5063), a potential treatment for schizophrenia and bipolar disorder. It’s a clinical-stage company, so no major revenue yet — but sentiment and short positioning are what make it interesting right now. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56–$0.58, and a breakout above that level could target $0.65–$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%–112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1–2 days Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all good signals. The stock recently broke from $0.43 → $0.55+ with strong volume and is trading above VWAP ($0.52). Support sits near $0.52, resistance near $0.56-$0.58, and a breakout above that level could target $0.65-$0.67. The short data is the key point: Short interest: ~13.8M shares (~20% of float) Borrow fee: 69%-112% APR (very high) Shares available to borrow: essentially zero Days to cover: ~1-2 days This combination - high short interest, rising borrow fee, and no availability - signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward. Pharmaceuticals Sector is gaining some traction lately. Been watching this stock for a while its on a reversal. It's trading above the VWAP on the 1 and 4 hour candle and SMMA is about to crossover the VWAP on the 1 hour candle. It's all good Short-Term (next 1–2 days): $0.67–$0.70: First resistance zone — expect profit-taking here. $0.75: Secondary breakout target if volume stays high. $0.80–$0.85: Stretch move — would need strong buying or short covering. Medium-Term (if squeeze continues or catalyst hits): $1.00: Major psychological level — likely where shorts start to cover more aggressively. $1.20–$1.50: Full squeeze potential zone if borrow fees remain elevated and volume spikes. $2.00+: Long-shot catalyst target — would require major positive trial or FDA-related news. Key supports: $0.58 (VWAP area) — needs to hold to keep momentum alive. $0.52–$0.55 — base support zone from earlier breakout. If $RVPH holds above $0.58 and breaks through $0.67–$0.70, the next short-term push could target $0.75+. Below $0.58, momentum fades and a pullback toward $0.52–$0.55 is likely. This combination — high short interest, rising borrow fee, and no availability — signals mounting squeeze pressure. If volume stays strong or any positive news drops, shorts could be forced to cover quickly, driving an aggressive move upward.

TrainingPumpkin6917

Very bullish data summary for Reviva Pharmaceuticals’ drug brilaroxazine from their Phase 3 “RECOVER” study. Here’s what it’s showing and how you should think about it: The data shows strong, sustained efficacy over one year in both acute and stable schizophrenia patients, with less than 1% discontinuation for symptom relapse - that’s exceptional for CNS drugs. It also highlights almost no significant side effects

Fair_Sock3309

**RVPH (Reviva Pharmaceuticals)** – Biopharma targeting schizophrenia & CNS disorders. Recent Phase 3 data for *Brilaroxazine* looks promising, but a $9M offering caused dilution and drop. Patents cover multiple indications; upside if FDA approval progresses. **TNMG (TNL Mediagene)** – Digital media + e-commerce + AI play with early GMV traction (\~$20M in 5 months). Adding crypto exposure via “digital asset treasury” gives optionality. Risk: micro-cap transparency, scaling to profit, crypto volatility. Could explode if revenue model sticks. **BURU (Nuburu Inc.)** – Blue-laser tech pivoting to defense, 3D printing, and industrial markets. New dual-CEO setup and planned defense-sector acquisitions signal growth push. Risk: delisting history, dilution, niche tech execution. Big upside if defense contracts land. **ADAP (Adaptimmune Therapeutics)** – Cell-therapy biotech restructuring after selling core assets to US WorldMeds for $55 M + milestones. Now refocusing pipeline (PRAME, CD70). Risk: early-stage assets and unclear growth path. Could rebound if new focus hits data success. **DFLI (Dragonfly Energy)** – Battery/energy-storage company riding clean-tech momentum; up 400% recently. Grant funding + solid growth projections (\~38%/yr) but revenue still shrinking and competition fierce. Risky momentum play with potential for continued breakout if execution improves. Some easy DD copy pasta from twitter

ElectroRush

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, PhD, Founder, President, and CEO of Reviva will participate in a fireside chat and key opinion leader (KOL) webinar hosted by A.G.P./Alliance Global Partners on October 10, 2025 at 11:00 AM ET. The webinar will feature an in-depth Fireside Chat with RVPH CEO Laxminarayan Bhat, PhD, and KOLs including Dr. Larry Ereshefsky, PharmD, BCPP, FCCP (Chief Scientific Officer, Follow the Molecule: CNS Consulting and Clinical Sciences by CenExel Research) and Dr. Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute, New York). The unmet medical need and current treatment landscape for patients suffering from symptoms of schizophrenia and the phase 3 clinical data of Reviva’s lead drug candidate brilaroxazine for schizophrenia will be discussed. The conversation will be moderated by A.G.P./Alliance Global Partners’ James Molloy.

Estakaliente01

Found it guys https://www.mdscongress.org/Sessions/IC25Sessions/4205.htm "Safety, tolerability, pharmacokinetics and pharmacodynamics of VTX3232, a CNS-penetrant NRLP3 inhibitor, in participants with early-stage Parkinson’s disease Mark Forman, USA" So, Mark Forman is the Chief Medical Officer for $VTYX. So the info of the presentation which is held in Hawaii by OP is true. Though, I have not found any info on the press released that should be at 2pm.

Repulsive_Ladder8137

[$RVPH](https://stocktwits.com/symbol/RVPH) CUPERTINO, Calif., Oct. 7, 2025 (GLOBE NEWSWIRE) — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a late-stage biopharmaceutical company developing therapies for central nervous system (CNS), inflammatory, and cardiometabolic diseases, announced that Founder, President, and CEO Dr. Laxminarayan Bhat will take part in a fireside chat and Key Opinion Leader (KOL) webinar hosted by A.G.P./Alliance Global Partners on October 10, 2025, at 11:00 AM ET. Found this on stocktwits

Some-Rent-7742

All you folks interested in TLRY: READ THIS! Everyone focuses on state dispensaries or adult-use legalization. The bigger catalyst is federal: DEA rescheduling to Schedule III → kills the 280E tax stranglehold, improves cash flow for operators, and makes capital easier to raise. FDA-approved cannabinoid drugs → potentially reimbursed by Medicare/Medicaid. CMS already covers FDA-approved cannabinoid meds like Epidiolex (CBD) and dronabinol (THC). That’s a real healthcare market, not just dispensary sales. So I’m aiming for exposure where those two currents overlap: pharma-grade cannabinoids, ancillary infrastructure, and real-estate cash flow.- My current holdings Zynerba (via Harmony Biosciences) – Transdermal CBD therapies for CNS disorders. Backed by Harmony’s resources, so more likely to get FDA approval and payer coverage than standalone biotech. Tilray (TLRY) – Major global cannabis operator. Broader exposure across medical, adult-use, and consumer packaged goods. Innovative Industrial Properties (IIPR) – This is my favorite “picks-and-shovels” play. A cannabis-focused REIT that buys specialized cultivation/processing facilities and leases them to state-licensed operators. They collect rent (many leases are triple-net), and rescheduling → 280E relief → tenants have stronger balance sheets → lower credit risk for IIPR. It’s essentially a way to get steady cash flow and dividends from the cannabis boom without plant-touching exposure. --- What I’m hunting next I want more U.S. pharma/ancillary exposure that will benefit from: Schedule III rescheduling (banking, taxes). FDA-approved cannabinoid drugs being covered under Medicaid/Medicare. Non-plant touching businesses (labs, packaging, compliance, logistics). Names on my radar: Green Thumb Industries (GTBIF) – Large MSO in the U.S. KushCo (KSHB) – Ancillary packaging/compliance. Other U.S. biotechs with cannabinoid pipelines. Raw CBD/hemp oil ≠ reimbursable. FDA-approved cannabinoid drugs = reimbursable. That’s where Zynerba/Harmony fits. Global names like Tilray = diversification. IIPR = steady cash flow, dividends, and less regulatory exposure. Rescheduling + CMS coverage would light up this space, but even before that, IIPR gives real fundamentals that most cannabis tickers lack.

Some-Rent-7742

My current holdings Zynerba (via Harmony Biosciences) – Transdermal CBD therapies for CNS disorders. Backed by Harmony’s resources, so more likely to get FDA approval and payer coverage than standalone biotech. Tilray (TLRY) – Major global cannabis operator. Broader exposure across medical, adult-use, and consumer packaged goods. Innovative Industrial Properties (IIPR) – This is my favorite “picks-and-shovels” play. A cannabis-focused REIT that buys specialized cultivation/processing facilities and leases them to state-licensed operators. They collect rent (many leases are triple-net), and rescheduling → 280E relief → tenants have stronger balance sheets → lower credit risk for IIPR. It’s essentially a way to get steady cash flow and dividends from the cannabis boom without plant-touching exposure.

Some-Rent-7742

My current holdings Zynerba (via Harmony Biosciences) – Transdermal CBD therapies for CNS disorders. Backed by Harmony’s resources, so more likely to get FDA approval and payer coverage than standalone biotech. Tilray (TLRY) – Major global cannabis operator. Broader exposure across medical, adult-use, and consumer packaged goods. Innovative Industrial Properties (IIPR) – This is my favorite “picks-and-shovels” play. A cannabis-focused REIT that buys specialized cultivation/processing facilities and leases them to state-licensed operators. They collect rent (many leases are triple-net), and rescheduling → 280E relief → tenants have stronger balance sheets → lower credit risk for IIPR. It’s essentially a way to get steady cash flow and dividends from the cannabis boom without plant-touching exposure. What I’m hunting next I want more U.S. pharma/ancillary exposure that will benefit from: Schedule III rescheduling (banking, taxes). FDA-approved cannabinoid drugs being covered under Medicaid/Medicare. Non-plant touching businesses (labs, packaging, compliance, logistics). Names on my radar: Green Thumb Industries (GTBIF) – Large MSO in the U.S. KushCo (KSHB) – Ancillary packaging/compliance. Other U.S. biotechs with cannabinoid pipelines. Raw CBD/hemp oil ≠ reimbursable. FDA-approved cannabinoid drugs = reimbursable. That’s where Zynerba/Harmony fits. Global names like Tilray = diversification. IIPR = steady cash flow, dividends, and less regulatory exposure. Rescheduling + CMS coverage would light up this space, but even before that, IIPR gives real fundamentals that most cannabis tickers lack.

Some-Rent-7742

- My current holdings Zynerba (via Harmony Biosciences) – Transdermal CBD therapies for CNS disorders. Backed by Harmony’s resources, so more likely to get FDA approval and payer coverage than standalone biotech. Tilray (TLRY) – Major global cannabis operator. Broader exposure across medical, adult-use, and consumer packaged goods. Innovative Industrial Properties (IIPR) – This is my favorite “picks-and-shovels” play. A cannabis-focused REIT that buys specialized cultivation/processing facilities and leases them to state-licensed operators. They collect rent (many leases are triple-net), and rescheduling → 280E relief → tenants have stronger balance sheets → lower credit risk for IIPR. It’s essentially a way to get steady cash flow and dividends from the cannabis boom without plant-touching exposure. --- What I’m hunting next I want more U.S. pharma/ancillary exposure that will benefit from: Schedule III rescheduling (banking, taxes). FDA-approved cannabinoid drugs being covered under Medicaid/Medicare. Non-plant touching businesses (labs, packaging, compliance, logistics). Names on my radar: Green Thumb Industries (GTBIF) – Large MSO in the U.S. KushCo (KSHB) – Ancillary packaging/compliance. Other U.S. biotechs with cannabinoid pipelines. Raw CBD/hemp oil ≠ reimbursable. FDA-approved cannabinoid drugs = reimbursable. That’s where Zynerba/Harmony fits. Global names like Tilray = diversification. IIPR = steady cash flow, dividends, and less regulatory exposure. Rescheduling + CMS coverage would light up this space, but even before that, IIPR gives real fundamentals that most cannabis tickers lack.

kukugege

Most small biotechs are drowning in debt, diluting nonstop, and chasing crowded markets. PSTV is different, almost zero debt, $17M+ in grants, a big UHN contract, and focused on rare CNS cancers. That combo is unique in this space.

ShortYam2876

Can't find ticker for pvst, did you mean pstv, if so,  their CNS testing launched through out Texas about 3 weeks ago and they entered into a partnership with UNH, news last week, giving them access to over 51M patients, I'm in it but do your own DD

BarracudaStill1960

"Plus Therapeutics Announces National Coverage Agreement with UnitedHealthcare For CNS Cancer Diagnostic Kit"

JandyRohnson

Plus Therapeutics Announces National Coverage Agreement with UnitedHealthcare Insurance Company for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer https://share.google/D77wEekJNegZE10o5 Seems like a big deal!

SomePolack

He's 100% dead dude, took a shot to the CNS and bled out near instantly

DankOubliette

Gilgamesh is privately held, and Abbvie are in acquisition talks - but whether this happens or not is still an open question. The earlier $1.95bn collaboration was a high water number for fees, millstones and ongoing royalties - they were paid $65m initially. For MindMed, their lead candidate still needs to go through Stage 3 clinicals. This remains a major hurdle (around 50% of drugs fail at this stage, with >85% of CNS & psychiatric drugs failing). Look at SAGE as a potential warning; even with an approval for postpartum depression, the markets didn’t treat them kindly as the MMD market was the prize! I consider any investment in this area to be highly speculative.

Minimum-Purchase7401

Overview of the Symposium This video captures an educational symposium presented at the 2025 SNO/ASCO CNS Metastases Conference. The focus is on leptomeningeal metastases (LM)—a particularly aggressive and challenging form of cancer spread affecting the brain and spinal cord.   ⸻ Key Highlights from the Presentation 1. Novel Treatment: REYOBIQ (Rhenium-186 Obisbemeda) • Plus Therapeutics presented the final results of their ReSPECT-LM Phase 1 clinical trial. • REYOBIQ is a targeted radiotherapeutic designed for direct intraventricular administration via an Ommaya reservoir—allowing high doses directly into the cerebrospinal fluid while minimizing systemic exposure.   • The trial demonstrated promising safety and efficacy signals in patients with LM.   • The trial received significant support, including a $17.6 million grant from the Cancer Prevention & Research Institute of Texas.   2. Continuing Research: Dose Optimization Trial • Following the primary trial, Plus Therapeutics has initiated a dose-optimization study to determine the best dosing for REYOBIQ. • This aligns with the FDA’s Project Optimus, aimed at improving dose finding strategies in oncology.  3. Educational Focus: Broader Strategies for LM • The symposium featured five leading neuro-oncologists who discussed the evolving landscape of diagnosing and managing LM. • Topics included insights into novel diagnostics (like CNSide Diagnostics), multidisciplinary approaches, and how REYOBIQ could fit into broader treatment strategies.   ⸻ Context: Why This Matters • Leptomeningeal metastases affect a small but serious subset of cancer patients (about 3–5%), particularly those with breast, lung, or melanoma cancers.   • Traditional treatments—such as radiation and intrathecal chemotherapy—have limited efficacy and come with significant challenges related to drug delivery across the blood-brain barrier. Prognosis often remains measured in weeks to a few months.   • Innovations like REYOBIQ represent an urgent, much-needed advancement in both targeted therapy and treatment delivery.

Minimum-Purchase7401

Watch or listen to the recording of the Leptomeningeal Metastases KOL Symposium from the SNO/ASCO CNS Metastases Conference 2025 https://youtu.be/GlQY8cU85EM?si=Z_p_yJKwHatgYBFL

WitchKitty777

My comment will likely get removed bc I don't post here enough, some BS like that, but here goes... CGTX is the only other bio stock I own other than AVXL (large position) and this is based on the SCIENCE. There is plenty of reason to believe that Z is a real contender when is comes to precision medicine based on biomarkers for CNS diseases. It is early yet, but this is the only other stock that has truly interested me in this space since AVXl came along well over a decade ago.

Woodsman8307

As someone with a current injury to my CNS / ANS, I can personally tell you that this isn’t the only effective therapy and there is one already in use today that isn’t a pharmaceutical and that isn’t patentable. I just got a series of them two weeks ago. Not saying this won’t go somewhere but it’s surely not some holy grail. A phase I trial is about as good as the paper it’s written on.

Freedom5567

mRNA is showing promise in prevention and immunotherapy, but it doesn’t address patients who already have brain or spinal metastases. Radiation (like Reyobiq delivers) goes where systemic drugs can’t - directly into the CNS. Different tools for different stages of cancer, and Reyobiq fills a gap where nothing else works right now.

PenguinnBets

**Plus Therapeutics (NASDAQ:PSTV)** presented positive data from their CNSide® Cerebrospinal Fluid (CSF) Assay Platform at the 2025 SNO/ASCO CNS Metastases Conference. The retrospective analysis, involving **613 CNSide assays** from 218 patients across 5 institutions, demonstrated significant capabilities in detecting and monitoring leptomeningeal metastases (LM). Key findings include **67% detection rate** of CSF tumor cells, with notable observations of immunocytochemistry and FISH probe detection changes in patients with multiple CSF draws. The platform showed **2.8 times higher diagnostic sensitivity** compared to standard CSF cytology and influenced clinical management decisions in **over 90% of LM cases**. [https://www.stocktitan.net/news/PSTV/plus-therapeutics-presents-positive-cn-side-csf-assay-platform-0yh6wolqkrpe.html](https://www.stocktitan.net/news/PSTV/plus-therapeutics-presents-positive-cn-side-csf-assay-platform-0yh6wolqkrpe.html)

Worried-Angle6504

Confirmed Dates & Events August  7, 2025 — Annual (Virtual) Meeting of Stockholders at 9:00 AM Eastern Time. August 14–16, 2025 — SNO/ASCO CNS Metastases Conference in Baltimore, MD (Baltimore Waterfront Marriott). Within the conference: August 14, 2025, 6:15 – 7:15 PM ET — LM Educational Symposium hosted by Plus Therapeutics, titled “Reimagining Your Approach to Leptomeningeal Metastases.” August 14, 2025, 7:15 – 9:00 PM ET — CNSide Diagnostics Presentation (FORESEE study: CSF Tumor Cell Detection) by Dr. Priya Kumthekar in Grand Ballroom VI. August 15, 2025, 3:25 – 4:50 PM ET — ReSPECT‑LM Trial Data Presentation (REYOBIQ safety and efficacy results) by Dr. Andrew Brenner in Grand Ballroom As you can see there's lots of catalysts coming yet I think even if a RS was to happen it doesn't matter at this point, you don't book out an entire hall for a conference to give BAD news!

Worried-Angle6504

Confirmed Dates & Events August  7, 2025 — Annual (Virtual) Meeting of Stockholders at 9:00 AM Eastern Time. August 14–16, 2025 — SNO/ASCO CNS Metastases Conference in Baltimore, MD (Baltimore Waterfront Marriott). Within the conference: August 14, 2025, 6:15 – 7:15 PM ET — LM Educational Symposium hosted by Plus Therapeutics, titled “Reimagining Your Approach to Leptomeningeal Metastases.” August 14, 2025, 7:15 – 9:00 PM ET — CNSide Diagnostics Presentation (FORESEE study: CSF Tumor Cell Detection) by Dr. Priya Kumthekar in Grand Ballroom VI. August 15, 2025, 3:25 – 4:50 PM ET — ReSPECT‑LM Trial Data Presentation (REYOBIQ safety and efficacy results) by Dr. Andrew Brenner in Grand Ballroom

Formal_Motor_6068

Since the acquisition of CNSide, we have laid the groundwork for a successful relaunch of CNSide in the US. Our preparatory activities are largely complete and we plan to reintroduce the product in Texas in the second half of 2025, extending that launch to all 50 states thereafter. Furthermore, in the past year, we achieved a number of key milestones for CNSide. First, we published multiple scientific articles highlighting the clinical value of CNSide. Second, the CNSide core test is now included in the National Comprehensive Cancer Center Guidelines. Third, we have completed and presented positive FORSEE clinical trial results. Fourth, we have built out a centralized testing laboratory in Houston and validated key commercial elements such as pricing and reimbursement. Finally, we have hired an experienced diagnostics executive team to lead Plus Therapeutics’ CNSide commercial subsidiary. We continue to believe that our CNSide platform uniquely fills a $6 billion market opportunity in the CNS cancer diagnostic space.

Zestyclose-Storm-270

$PSTV all day! PSTV is not a pump... And it's not diluting.. they are generating money and in the green !! don’t sell, and if you’re not in yet, now’s the time PSTV is going commercial with CNSide, the first platform to detect brain tumors using spinal fluid — no surgery needed. They’re also launching a first-of-its-kind treatment for the two deadliest brain cancers. Key catalysts that change everything are the August 7th Shareholder meeting, August 14th is their earnings report. On August 14–16, they are Presenting at the SNO/ASCO CNS Metastases Conference. Where they will be sharing their clinical trial success with REYOBIQ and discuss the successful initial rollout of their CNSide platform. They will also demonstrate this platform LIVE!!! This isn’t speculation.. ITS NOT A PUMP... it’s happening now. Price targets are as high as $30. Short term target at $3-$5 The current price is still under $1. The upside is real. Hold your shares. Or get in before the market wakes up.

Zestyclose-Storm-270

Plus Therapeutics (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on CNS cancer treatments, has announced a major restructuring of its $15 million March 2025 equity financing. The restructuring eliminates potential dilution of up to 1.5 billion shares of common stock. Following the restructuring, only around 36 million shares are now issuable upon exercise of amended Series B Warrants. while there were initial concerns about potential significant dilution with the March 2025 financing, the subsequent restructuring was aimed at significantly mitigating that risk by reducing the number of potential shares and canceling a large number of warrants.

Zestyclose-Storm-270

PSTV is trading under at around .60 cents today. That’s penny stock territory. But they aren’t some BS shell company waiting on a miracle. PSTV is already making waves with a platform that could revolutionize how we treat brain cancer. We’re talking real-world use, not fantasy science. The Catalyst That Changes Everything: In LESS THAN 14 DAYS they are going commercial with CNSide, a first-of-its-kind liquid biopsy platform that detects brain tumors using spinal fluid.. no surgery required!!! Read that again. Let that sink in. A non-invasive diagnostic method for brain cancer. That's never been done before. That alone puts them in a league of their own. BUT WAIT, THERES MORE! Within the same month, they’re presenting their clinical results for drug REYOBIQ!! a drug that targets and kills the two deadliest forms of brain cancer: glioblastoma and leptomeningeal metastases. They have had OVERWHELMING success according to sources. Also a world first!! This Month is Critical And getting in ASAP is priority and Here's Why: August 14-16: PSTV presents at the SNO/ASCO CNS Metastases Conference, where the world will get a look at what they’re doing. This conference has sent similar biotech stocks FLYING. This is not a waiting game. The company is moving NOW. They’ve already received multiple designations from the FDA, including Orphan Drug and Fast Track. Including over 18 million dollars in government grants and the backing/support of world renown cancer institutes, colleges, doctors, and scientists. Why This Could Make You Rich FAST?? Market cap is tiny: under $20M. One solid press release or clinical success, and this thing WILL explode. They’re not diluting. and voting against reverse splits! They're focused. And they’ve got a legit science team backing everything up. Price Target: Analysts and sentiment on social media are pointing toward $3–$4 in the short term, and $10+ long term! The highest bull price target is $32!!! Which honestly isn’t off the table as data and commercialization unfold. If You Missed Out On: NVAX before COVID MRNA before it went viral BNGO before genomics became hot Then PSTV is your Second chance.

Zestyclose-Storm-270

I have done a couple other DD posts on this that have gained some traction. But there is REAL movement happening and this pop is going to hit ANY day now! So RIGHT NOW might be the perfect time to jump in on PSTV. A short-term move to $3–$4 looks likely within the next couple weeks. I spent about 2 hours getting all of this laid out for this post. So I hope my DD does SOME justice.... Commercial rollout of their CNSide platform is underway. (Quite literally going public with the next 14 dayys, MAX) with plans to slowly distribute nationally over the next 13 months. They have the backing of a very major hospitals and institutions, and have been praised by renown doctors and scientists around the country. Let's not forget the over $18 million dollars in grants they've already received from the government as well. They’re presenting at the SNO/ASCO CNS Metastases Conference (August 14–16) a MAJOR event with MANY eyes on their tech. This isn't one of those “wait and hope” biotechs. PSTV is already active, progressing on multiple fronts. Analysts have given it targets between $10–$15, with a max bull case at $32. Not hype AT ALL... There is real institutional coverage backing this. And if all that wasn't enough... we have, The REYOBIQ Catalyst PSTV’s drug REYOBIQ is showing overwhelming success in clinical trials for treating leptomeningeal metastases... one of the toughest brain cancer-related conditions known to man. This is a summary report directly from stock titan... "Plus Therapeutics (NASDAQ:PSTV) has announced the successful treatment of initial patients in its ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re186 obisbemeda) targeting leptomeningeal metastases (LM). The trial follows promising Phase 1 results where 5 out of 7 patients achieved over 80% reduction in LM tumor cells and survived at least one year post-treatment. The dose optimization study, supported by a $17.6 million CPRIT grant, aims to determine optimal dosing for efficacy and safety in alignment with FDA's Project Optimus. The company expects to complete Cohort 1 enrollment by year-end and plans to present additional Phase 1 data at the SNO/ASCO CNS Metastases Conference in August 2025." So there you have it ...This is EVERYTHING I have... I've laid it All out on the table for you. I did all my own DD. Typed MOST of this out. And used chat GPT only to cut through some of the fat. This is shaping up to be huge. Not a long term waiting game...catalysts are already in motion. Do your own due diligence, but don’t sleep on this. The train is moving. I want US ALL to eat. So get in while you can 🥂

Matched-Energy3196

Ticker: $BTAI Sector: Biotech / Neuropsychiatry Thesis: Significant upside potential ahead of key August catalysts — a strong setup for a breakout on compelling clinical and regulatory developments. 🔬 Company Overview BioXcel Therapeutics (BTAI) is a clinical-stage biopharmaceutical company using AI-based drug repurposing to develop therapies in neuroscience and immuno-oncology. Its lead asset, BXCL501 (Igalmi), is a sublingual film formulation of dexmedetomidine being developed for acute agitation in various psychiatric and neurological conditions. The company already received FDA approval for BXCL501 for agitation associated with schizophrenia and bipolar I/II disorder. Now, it's aiming to expand the label significantly — and that’s where the August 2025 catalysts come in. 📅 Upcoming Catalysts ✅ 1. Data Readout – Q3 2025 (Expected early August) BTAI is expected to release pivotal Phase 3 data any day now for BXCL501 in acute agitation related to Alzheimer’s-related dementia (AARD). This is a high unmet need indication with no FDA-approved treatments. Positive data would solidify BXCL501 as the first and only noninvasive treatment for this population, greatly expanding its commercial potential. Why it matters: The AARD population is large and growing. Caregivers and hospitals face limited options for managing agitation — often resorting to antipsychotics or physical restraints. A positive readout could increase the addressable market by 3–5x. 🗓️ 2. Pre-NDA Meeting – August 20, 2025 The company has already requested a Pre-New Drug Application (Pre-NDA) meeting with the FDA for the dementia agitation indication. This is a formal step toward regulatory approval, and a successful outcome (with FDA alignment) would allow BTAI to submit an NDA before year-end, triggering milestone payments and setting up for 2026 commercialization. 💡 Why This Setup is Bullish Low Float + Short Interest BTAI has a low float, and short interest remains elevated. A positive data readout can trigger a short squeeze in a thinly traded name. Undervalued vs. Peak Sales Potential Even a modest penetration into the dementia agitation market could drive $300M–$500M in annual sales, compared to a current market cap below $100M. BXCL501’s platform potential (already FDA-approved) positions it well for label expansions with minimal clinical risk. Derisked Mechanism Dexmedetomidine’s safety profile is well-characterized, and BXCL501 has already been through multiple successful trials. The regulatory path is well-defined, and BXCL501's success in prior CNS indications improves odds of FDA acceptance. Strategic Optionality A favorable meeting on August 20th opens the door for partnerships, licensing deals, or M&A interest. The company previously guided that it intends to monetize the asset through ex-US partnerships, which may be announced post-readout. 🧠 Summary BTAI presents a near-term, asymmetric risk/reward play with two major binary events in August: a high-impact data readout followed by a regulatory milestone. With a strong setup, derisked asset, and massive market opportunity, bulls are positioning for a breakout on positive news. 📊 Data readout (early August): High probability of success based on prior trials and unmet need. 🧾 Pre-NDA Meeting (Aug 20): Catalyst for de-risking FDA submission. 💰 Valuation upside: Potential for 3–5x re-rating if catalysts go well. PT if successful: $8–$12 range

Zestyclose-Storm-270

Ok so the time to get in is ASAP. This is a LIVE company. Their CNSide platform rolls out commercially within the next 14 days... The perfect time to get would have been on Thursday. We are already up 20% in one day. As for if it is a short term or long term? Let's talk about what the company is doing. Their CNSide platform is rolling out ANY day now. This is going to be starting in only Texas but has the backing of national cancer institute, several renown doctors,physicians, scientists.. And is being rolled out to several hospitals and institutions IMMEDIATELY. Then over the next 13 months they will slowly distribute nationally. This ALONE is an amazing driving factor/catalyst They are having overwhelming success in their clinical trials with their Lead drug REYOBIQ. It is designed to deliver a high dose of radiation directly to tumors in the brain and central nervous system while minimizing harm to surrounding healthy tissues. Plus Therapeutics also has another product in preclinical development called 188RNL-BAM,. This therapy aims to treat solid organ cancers, including primary and secondary liver cancers. They will be presenting at the SNO/ASCO CNS Metastases Conference in Baltimore, MD from August 14-16. They will be showcasing two presentations related to their CNSide platform. One presentation will focus on the ReSPECT-LM clinical trial results, and the other will be an educational symposium.

Zestyclose-Storm-270

Your right. I definitely should have taken the time to clean up the post before I posted it. If you make it too fancy, everyone assumes it's AI and writes you off. And again.. my apologies. It isn't an FDA meeting, but rather an upcoming presentation at the SNO/ASCO CNS Metastases Conference on August 14–16,

PromotionOk3118

TNF Pharmaceuticals Inc. (TNFA) is primarily focused on developing two novel therapeutic platforms: 1. **Isomyosamine (MYMD-1®):** This is their lead drug candidate and is a clinical-stage, synthetic plant alkaloid. * **Mechanism of Action:** Isomyosamine is an oral, next-generation TNF-alpha (TNF-α) inhibitor. TNF-α is a key inflammatory cytokine (an immune cell signaling protein) that plays a crucial role in initiating and maintaining inflammation, insulin resistance, and the aging process. Isomyosamine selectively blocks TNF-α action where it is overactivated, without preventing it from performing its normal functions in response to routine infections. It also modulates other pro-inflammatory cytokines like IL-6 and IL-17A. Additionally, it has shown similar biological activities to mTOR inhibitors like rapamycin, which are known for their lifespan-extending properties. A significant advantage is its oral dosing, unlike many currently approved TNF-α blockers that require injections or infusions. It can also cross the blood-brain barrier, which could allow it to treat CNS-based autoimmune and inflammatory diseases. * **Indications in Development:** * **Sarcopenia/Frailty:** This is a primary focus, with a Phase 2b clinical trial initiated to further explore its efficacy in preventing progressive muscle loss and frailty, including in patients with acute post-surgical inflammation and complications from hip or femur fractures. They are also planning a trial for GLP-1-induced sarcopenia and frailty (muscle loss associated with weight-loss drugs like Wegovy/Ozempic). * **Autoimmune Diseases:** Isomyosamine is being developed to treat various autoimmune and inflammatory conditions, including: * **Aging and Age-Related Diseases:** The company is exploring its potential to slow the aging process and extend healthy lifespan, given its immunometabolic regulating properties and comparison to rapamycin in preclinical studies

That-Fun-7760

**[DD] $PSTV (Plus Therapeutics) – 2025 Radiotherapeutics Microcap Deep Dive** **TL;DR:** PSTV is a high-risk, clinical-stage microcap focused on new radiotherapeutics for tough-to-treat brain/CNS cancers. They’ve made clinical progress, landed FDA designations, and are launching a novel diagnostic, but face massive dilution, high losses, low institutional support, and surging short interest. Very speculative. **1. What is PSTV?** - U.S.-based biotech developing targeted radiotherapies (REYOBIQ™) for CNS cancers: recurrent glioblastoma, leptomeningeal metastases, pediatric brain tumors. - Also launching CNSide™, a diagnostics platform for CNS tumor cell detection. - CEO: Marc Hedrick; moved HQ to Houston in 2025. **2. Stock & Cap Table (July 2025):** - **Price:** $0.58 (volatile, up 47% in 2 weeks) - **Market Cap:** $32–35M - **Shares Out:** 60.5M (up 153% YoY, due to dilution) - **Float:** ~60.4M - **Insider Ownership:** 0.16% - **Institutional Ownership:** 0.6% - **Beta:** 1.7 **3. Key Financials:** - **TTM Revenue:** $5.2M (Q2: $1.06M, –37% YoY) - **Net Loss (TTM):** –$27.1M (–$3.50/share) - **Cash:** $9.9M (Q2 2025) - **Book Value:** –$23.6M (negative equity) **4. Valuation & Ratios:** - **P/S:** 0.94x (sector median >3x) - **P/B:** Negative - **Piotroski F-Score:** 3–4 (weak) - **Short Interest:** 6–12% of float, borrow rates high - **Forward Multiples:** N/A (no profitability forecasted) **5. Institutional & Insider Info:** - **Major Holder:** Virtu Financial (small, old position) - **Funds:** Only 0.6% institutional, minimal recent buying - **Insiders:** No recent notable trades **6. Recent Catalysts/News:** - **$50M equity-line (Lincoln Park Capital):** 17M new shares registered, expect more dilution - **CNSide™ diagnostic:** U.S. rollout starts 2H 2025 (Texas first) - **FDA news:** IND cleared for pediatric high-grade glioma (REYOBIQ™) in June, $3M DoD grant - **Q2 earnings:** Expected August 13, 2025 **7. Pipeline/Clinical Data:** - **Lead drug:** REYOBIQ™ (targeted CNS radiotherapy) - **Leptomeningeal metastases:** Phase 1 done; strong safety, recommended Phase 2 dose set - **GBM:** Phase 2 enrolling; interim data promising for dose/survival - **Pediatric IND:** Cleared, trial starts late 2025 - **CNSide™ diagnostics:** 92% sensitivity; commercial launch ready **8. Analyst & Retail Sentiment:** - **Consensus:** Moderate Buy (2 Buy/2 Hold, per MarketBeat) - **PT Range:** $8–11+ (reflects best-case future) - **Retail sentiment:** Not a meme, but trending up after recent news and shorts squeezing - **Short interest:** Up 390% in a month; high crowding risk if volume spikes **9. Risks:** - Huge dilution; 150%+ shares added YoY, more likely soon - Negative book value, heavy and persistent cash burn - Short interest climbing (potential for squeeze but also for new lows) - Clinical/commercial execution risk; pipeline readouts and adoption take time **10. Catalysts Ahead:** - **Aug 13, 2025:** Q2 earnings - **Aug 15, 2025:** Final ReSPECT-LM results at SNO/ASCO CNS Metastases conf - 2025: Pediatric trial launch, CNSide™ U.S. expansion **Summary Table** | Metric | Value (July 2025) | |---------------------|----------------------| | Price | $0.58 | | Market Cap | $32-35M | | Shares Out | 60.5M (+153% YoY) | | Institutional Ow. | 0.6% | | Insider Ow. | 0.16% | | Piotroski F-Score | 3–4 | | P/S | 0.94x | | Cash | $9.9M | | Short Interest | 6–12% of float | | Next ER | Aug 13, 2025 | | Pipeline Milestone | SNO/ASCO Aug 15 | **Bottom line:** PSTV is a classic high-risk biotech: novel clinical assets, unproven diagnostics, wildly dilutive, and minimal institutional/insider support. If trials and commercial launch hit, there’s multibagger upside, but the downside is further dilution, reverse split risk, or fading into obscurity. **Speculative only. DYOR!**

Rare-Dragonfruit-246

$PSTV – Legit sleeper biotech w/ real near-term catalysts Trading under $1 and flying under the radar. Just filed to WITHDRAW their S-3 offering – which means no dilution for now. That alone is rare in this market (IXHL anyone?). Here’s why I’m watching: ✔️ They specialize in targeted radiotherapeutics for rare, aggressive cancers – like glioblastoma (GBM) and leptomeningeal metastases (LM). Big unmet needs. ✔️ Lead candidate Rhenium-186 is in Phase 1/2 trials for multiple indications and has Orphan Drug + Fast Track designation. ✔️ Key upcoming catalyst: REYOBIQ (rhenium Re186 obisbemeda) - (ReSPECT-LM) Phase 1 data to be presented at SNO/ASCO on August 15, 2025. Phase 2 trial initiation planned. 3 ✔️ Key upcoming catalyst 2 : CNSide - (FORESEE) Presentation due at SNO/ASCO CNS on August 14, 2025. Trial data reported that the trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases, surpassing the 20% primary endpoint target, noted August 13, 2024. Additional trial data demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM, noted November 22, 2024. ✔️ Recently granted FDA Rare Pediatric Disease Designation for LM – this opens up eligibility for a priority review voucher, worth $$$ if granted. ✔️ Clean cap table for now – no recent dilution, and they pulled the S-3. Either they’re confident in data or another non-dilutive funding route is coming. ✔️ Plus Therapeutics has restructured its $15 million equity financing to eliminate potential dilution of up to 1.5 billion shares. ✔️ Market cap is under $35M. One good PR and this thing could fly, like we’ve seen happen with other sub-$1 biotechs recently. Target: 1.8–4$ short-term if data is clean.

Rare-Dragonfruit-246

$PSTV – Legit sleeper biotech w/ real near-term catalysts Trading under $1 and flying under the radar. Just filed to WITHDRAW their S-3 offering – which means no dilution for now. That alone is rare in this market. Here’s why I’m watching: ✔️ They specialize in targeted radiotherapeutics for rare, aggressive cancers – like glioblastoma (GBM) and leptomeningeal metastases (LM). Big unmet needs. ✔️ Lead candidate Rhenium-186 is in Phase 1/2 trials for multiple indications and has Orphan Drug + Fast Track designation. ✔️ Key upcoming catalyst: REYOBIQ (rhenium Re186 obisbemeda) - (ReSPECT-LM) Phase 1 data to be presented at SNO/ASCO on August 15, 2025. Phase 2 trial initiation planned. CNSide - (FORESEE) Presentation due at SNO/ASCO CNS on August 14, 2025. Trial data reported that the trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases, surpassing the 20% primary endpoint target, noted August 13, 2024. Additional trial data demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM, noted November 22, 2024. ✔️ Recently granted FDA Rare Pediatric Disease Designation for LM – this opens up eligibility for a priority review voucher, worth $$$ if granted. ✔️ Clean cap table for now – no recent dilution, and they pulled the S-3. Either they’re confident in data or another non-dilutive funding route is coming. ✔️ Plus Therapeutics has restructured its $15 million equity financing to eliminate potential dilution of up to 1.5 billion shares. ✔️ Market cap is under $15M. One good PR and this thing could fly, like we’ve seen happen with other sub-$1 biotechs recently. Target: 1.8–4 short-term if data is clean.

frisby-research

**New Deep Dive: Cognition Therapeutics ($CGTX)** Cognition is a microcap CNS company developing an oral Alzheimer’s and DLB drug, backed by $47M in NIH grants. It trades around a $40M market cap—effectively at cash—despite multiple mid-stage trials and near-term data catalysts. In this report, we cover: • The science behind sigma-2 receptor modulation • Valuation modeling (rNPV and peer comps) • Bull, bear, and base case outcomes • Why we assign a conviction score of 8.3/10 • Target valuation: $150–175M If CGTX delivers, we think it re-rates sharply. If not, the downside is mostly priced in. **Read the full analysis here:** [https://frisbyresearch.substack.com/p/1-undervalued-nih-backed-and-near](https://frisbyresearch.substack.com/p/1-undervalued-nih-backed-and-near)

lmaoubadd

PSTV play in since 0.38 Plus Therapeutics (PSTV) has several significant catalysts on the horizon, primarily linked to its flagship programs, REYOBIQ™ (a radiopharmaceutical for central nervous system tumors) and the CNSide™ diagnostic platform. Here are the main catalysts investors should watch for: REYOBIQ™ (Radiopharmaceutical) * Clinical Data from ReSPECT-LM Trial (Phase 1 Multi-Dose): * Enrollment Completion and Safety Data: The company expects to complete patient enrollment and present safety data by the end of the year. * Conference Presentations: Presentations of efficacy and immune response data for REYOBIQ™ are anticipated at medical conferences, including the SNO/ASCO CNS Metastases Conference (August 14-16, 2025). Results from the ReSPECT-LM trial were recently presented on July 15, 2025. * Regulatory Discussions with the FDA: The company plans to complete its end-of-Phase 1 meeting with the FDA for the ReSPECT-LM study and define the next clinical steps in 2025. There's a potential for Fast Track designation. * ReSPECT-GBM (Phase 2) Enrollment Completion: Plus Therapeutics expects to complete enrollment for the Phase 2 ReSPECT-GBM (recurrent glioblastoma multiforme) study in 2025. * REYOBIQ™ for Pediatric Brain Cancer: Recently (June 25, 2025), the FDA authorized the Investigational New Drug (IND) application for the use of REYOBIQ™ in treating pediatric brain cancer. This will pave the way for a Phase 1/2a clinical trial for children with high-grade glioma and ependymoma. CNSide™ (Diagnostic Platform) * U.S. Commercial Launch: Plus Therapeutics plans the commercial launch of its CNSide™ diagnostic platform in the United States in the second half of 2025. Initially, the launch will be in Texas, with subsequent expansion to other states. This platform aims to quantify tumor cells and circulating tumor DNA in cerebrospinal fluid for early diagnosis and treatment monitoring of leptomeningeal metastases. * Conference Presentations: There will be presentations on the diagnostic utility of CNSide™ at medical conferences, including the SNO/ASCO CNS Metastases Conference (August 14-16, 2025).

PaymentNecessary1667

That happened to me, it was CNS (central nervous system) and it was a section of the spine the professor had all the tracks labeled with these pins that looks like one color. Found out I was a deuternope something like this

jefbe80

$PSTV We have good news!!! PSTV makes U.S. commercial rollout of novel diagnostic platform to begin second half 2025 Underserved CNS cancer diagnostic U.S. market opportunity estimated to be in excess of $6 billion.

jefbe80

Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma. The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense.

jefbe80

PSTV The last part of this investors communication is key, Comprehensive restructuring eliminates the potential issuance of up to 1.5 billion shares of common stock Plus Therapeutics files a request to withdraw the related resale registration statement with the SEC HOUSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces a comprehensive restructuring of its previous $15 million equity financing announced on March 4, 2025. This strategic restructuring eliminates potential dilution of up to 1.5 billion shares of common stock, which the Company believes will significantly enhance shareholder value and position the Company to move forward with a more straightforward equity capital structure. KEY HIGHLIGHTS OF THE EQUITY FINANCING RESTRUCTURING Elimination of Dilutive Warrants: The restructuring cancels warrants associated with the equity financing, which could have resulted in the issuance of up to 1.51 billion shares of common stock, leaving approximately 36 million shares of common stock issuable upon exercise of amended Series B Warrants at an alternative cashless exercise ratio of 1:1 Cancellation of Common Stock and Pre-Funded Warrants (PFWs): The restructuring will lead to the cancellation of approximately 25 million shares of common stock (or PFWs in lieu), further reducing stockholder dilution Future Financing Provisions: The Company will use 90% of future proceeds from any capital raised subsequent to July 1, 2025 to repay the holders of 22,727,270 shares of common stock (or PFWs in lieu) at 115% of the price originally paid for such securities in the March 2025 Equity Financing, based on an effective initial price of $0.66 per share Here it says they will raise capital but it is my belief that they are going to have good news, so they are projecting raising capital in better conditions.

BeginningRoad1661

Buru has acquisition news coming with Tekne. See company twitter page. And Pstv has clinical trial news relating to its drug Reyobiq which is a radiotherapy drug for CNS cancers

leomeng

Someone will want their CNS portfolio.

Routine-Courage-3087

Introducing the stock that you’ve never heard of that will make me a millionaire. NervGen Pharma, $NGENF. Currently there are 0 cures to spinal cord injury derived paralysis, not a single one. 0 ways repair the central nervous system. This means Spinal Cord Injury, MS, ALS, and many more are untreatable, that is until now. NervGen Pharma is based off the revolutionary work of late Doctor Jerry Silver who found that after injury to the spinal cord/Central nervous system(CNS), scars form around the nerve endings. Previously nobody knew what prevented the CNS from repairing itself the way a cut on our skin or broken bones do. Dr. Silver theorized these scars were the reason behind the prevention of the body healing itself within the CNS. After testing this is animal models in preclinical trials on rodents, they found after spinal cord injury in rodents, rodents were able to regain a remarkable amount of function or their lost limbs after spinal cord injury. The trials were a great success. After that the company’s main drug, NVG-291, was tested to be safe in healthy individuals in phase 1a clinical trials and the only noticeable affect was a temporary small red rash at the site of injection(keep this in mind). The trials were a success and fully safe for a fact and approved by the fda to test for efficacy in phase 1b/2a trials. This is where we are currently however there’s more to know. The trial is set up with 40 total participants split into 2 groups of 20. (1)Those who have been injured for 20-90 days and (2)those who have been injured for 1-10 years. Within those groups of 20 there are 10 who will be given a placebo and 10 who will be given the drug, NVG-291. Those who receive the drug are given it daily for 4 months at the highest dose tested for safety in the phase 1a clinical trials. Data was set to be released only when both groups have completed the trial however one group has already completed their and the data for that group is set to be released early June. HOWEVER, the juicy part is that there have been rumors from the participants in the trial that received the drug that it has worked. Mainly one story is that a patient went from walking 30 feet in just over 15 minutes before the drug to 45 seconds after receiving the drug. This is groundbreaking. That is because not only is this significant recovery from spinal cord injury very rare, but ALSO after one year since injury it is thought that any recovery after is next to impossible. These leaks were from the group that has been injured for over a year so this progress is INSANE. ON TOP OF THAT, the one who leaked explained that they didn’t know if they received the drug or placebo because the study is blinded however they did notice that same red rash when they were given their shots. The same red rash from when the drug was given is earlier trials that the placebo probably didnt give. The placebo wouldn’t have this effect at all. I myself tracked down and verified this information through the patients donation page and routine updates from the family of the patient themselves on caringbridge. On top of that the company could charge insane amounts for this drug based on the lifetime cost of living with a spinal cord injury. This stock is also microscopic, with a market cap of under 200 million. Companies with similar or somewhat worse results have seen a valuation of 2.6Billion(Look at history of Longbridge Pharmaceuticals). Even more, the stock isn’t even listed on all major brokerages like Robinhood and when this stock hits those exchanges and news is realeased to this public this stock in my opinion will do something we may never get the chance to see in our lifetime as well. Everything I have researched points to putting at least SOMETHING in this stock and I really do think this is the opportunity of a lifetime for those that seize it. https://www.caringbridge.org/site/9296f6ac-fd25-3f9e-ae12-a84a95010608read this

Beastious

✅️Elite Pharma (ELTP) Catalyst :✅️ ✅️ 1. Cash Flow Positive ✅️ 2. Purchase building housing their cGMP registered facility for research, development, manufacturing and packaging of pharmaceutical products. ✅️ 3. Adderall IR $421.7 Million IMS market Approved and Launched ✅️ 4. Adderall XR $865 Million IMS market Approved and Launched ✅️ 5. Double digit quarterly revenues in millions ✅️ 6. Create in house marketing and distribution: Kirko Kirkov, Doug Plassche and their teams ✅️ 7. DEA increases manufacturing quotas for Adderall & Vyvance ✅️ 8. Generic OxyContin - FIRST TO FILE FDA Aug 17, 2023 $720 Million ✅️ 9. Generic Vyvanse - $4.3 BILLION - FDA submission Dec 2023 ✅️ 10. FDA Acceptance of Generic OxyContin Sept 2023 ✅️ 11. Lease additional manufacturing space and storage vault for new Needle Mover ANDAs - Jan 2024 __12. Obtain Full ownership of Adderall IR $ 421.7 Million from MIKAH __13. Obtain Full ownership of Adderall XR $ 865 Million from MIKAH ✅️ 14. Generic Methotrexate Antimetabolite- Approval ✅️ 15. Launch generic Methotrexate $63 Million ✅️ 16. $50+ million in yearly revenues ✅️ 17. Lowest PE ratio for OTC Healthcare sector ✅️ 18. Become the ONLY company showing rapid growth on the OTC while being profitable ✅️ 19. Put Opioids back on the Table- due to reduced risk of opioid litigation ✅️ 20. Receive Analyst Coverage - Upgrade to Market Outperform - Zacks Investment Research ✅️ 21. International Distribution - partnership Approval by Israeli Ministry of Health for European distribution License and Distribution Agreement by and between Elite Pharmaceuticals, Inc. and Dexcel Ltd. ✅️ 22. Generic IR Adderall® Receives Marketing Approval From The Israeli Ministry Of Health Oct 2024 ✅️ 23. Final Approval of New Manufacturing Facility/Expansion __ 24. Generate revenues over $20 million/quarter —- Imminent __ 25. Generate revenues over $30 million/quarter __ 26. Generate revenues over $40 million/quarter __ 27. Generate revenues over $50 million/quarter ❓️ 28. Double output of manufacturing and packaging facilities —-Imminent ✅️ 29. Launch approved generic Tylenol with Codeine $47 Million ✅️ 30. Launch approved generic Norco - hydrocodone acetaminophen IMS $300 Million ✅️ 31. Launch approved generic Percocet - oxycodone acetaminophen IMS $317 Million __ 32. Launch approved generic Dolophine - methadone HCL tablets IMS $30 Million __ 33. Dopamine Agonist Approval (probably Requip XL or Mirapex ER). $12 Million ✅️ 34. Generic Vyvanse (The Golden Goose) Approval $4.3 Billion __ 35. Indian Research and Development agreement __ 36. Positive BE Study for Concerta CNS Stimulant $1.16 Billion ✅️ ✅️ ✅️ 37. LAUNCH $4.3 Billion Generic Vyvanse Dec 2024 __38. Generic Concerta- FDA submission $1.16 Billion __39. Launch Adderall IR in Israel —Imminent __40. 100 million in yearly revenues —-2025 __41. Generic OxyContin Approval $720 Million ✅️ 42. Accord prevail over Purdue in Generic OxyContin infringement suit - Dec 30, 2024 https://cafc.uscourts.gov/opinions-orders/23-1953.OPINION.12-30-2024_2443222.pdf __43. Elite prevail over Purdue in Generic OxyContin infringement suit. https://www.pacermonitor.com/public/case/51356241/PURDUE_PHARMA_LP_et_al_v_ELITE_LABORATORIES_INC,_et_al __43. Launch generic OxyContin $720 Million __44. Positive BE on NDA Unique ADF opioid - 90% cheaper than ADF without Naltrexone __45. Resume R&D on SequestOx Abuse Deterrent Oxycodone __46. $200 million in yearly revenue __47. Patented NDA Unique ADF (w/o naltrexone) drug C in SequestOx reformulation trial __48. Undisclosed Mikah ANDA(s) __49. Undisclosed ANDAs/NDAs __50. Generic Concerta Launch $1.16 Billion __51. DollarLand PPS ——2025 __52. Uplist to NASDAQ exchange __53. M&A advisory firm selected for buyout __54. Perform Business Valuation __55. Develop strategy set for sale of business __56. Prepare marketing materials for sale __57. The advisory firm begins to identify and approach potential buyers. __58. Management teams present the company's strengths and growth potential to interested buyers __59. Site visits by potential Buyers to inspect and meet management. __60. Begin Buyout Negotiations __61. Buyout offer/s __62. Buyer Identified __63. Purchase Definitive Agreement __64. Buyout Vote of Board of Directors __65. Halt Trading __66. Shareholder vote on offer __67. Necessary regulatory approvals are obtained for transfer of ownership __68. Buyout Closing Completed —$$$$$$$$$$$ __69. Vegas BABY !!!!! 🎰

Live-Law-5146

Lilly is also trading at >3x PE compared to NVO which is just 18 P/E (TTM) and even lower forward. I think the notion that Lilly's drugs completely outcompete NVOs is overblown. Price erosion is already happening, and right now Wegovy is the only one being prescribed for various reimbursements due to its approval for heart disorders. The biggest mistake was during the short supply where GPs started to prescribe Lilly drugs since Wegovy was clogged up. I think they lost a lot of momentum then. NVO is not just a obesity company, they have best-in-class bleeding disorder drugs, moving into gene therapies, and various late stage programs in other areas. Their GLP1s are already showing good data in CNS disorders (Alzheimer’s, Parkinson's), and they could be first-in-class with Phase 3 in oral GLP1 for AD. Personally, I would not bet against them, but at the same time, who knows where the bottom is. But it will increase upon new CEO being named. Lilly on the other hand, I would not touch at the multiple they are carrying. They are not a high growth company, it is big pharma, a heavily regulated industry, highly sensitive to pipeline developments (clinical trial risks), buyout opportunities (in competition with other companies fo rtheir pipeline), and the reimbursement scene which already have seen pressure for the last 10 years. The P/E they are carrying makes it hard to make them a good buy, when you have GOOGL at 18 P/E, and other companies growing vastly more.

Routine-Courage-3087

yes hundreds of thousands and the cost of living with one is insane for insurance companies, telling you first hand. They’d be willing to pay anything that saves them money in long run. Also, they are working on treating other issues within the CNS, see NVG-300 but not as developed as this one

Reeeeeekola

ELV, CVS,.CNS ....   CI fwd PE is 9.   You are looking at TTM which is useless.

h3xpl01t

Hey, love this breakdown — thanks for bringing $VTGN back on the radar! That fasedienol angle is interesting, especially the part about non-sedative, fast-acting treatment for Social Anxiety Disorder. A couple quick questions though: * Did they share any new data on efficacy or just reiterate prior findings at the ADAA conference? * Do you know where they are in the FDA timeline — are we expecting Phase 3 readouts soon or still in mid-stage? * Any word on how they plan to commercialize fasedienol if approved — partner, go solo, or license it out? Also, out of curiosity, how do you think $VTGN stacks up right now against some other CNS/mood-focused names like: * **$MNMD (MindMed)** – Also targeting anxiety but with a psychedelic pipeline (MM-120 for GAD). Higher risk, but also drawing attention for novel mechanisms. * **$AXSM (Axsome Therapeutics)** – Their AXS-05 (approved for depression) gives them a revenue-generating foothold while they explore more indications. Stronger fundamentals but less upside room maybe? * **$PRAX (Praxis Precision Medicines)** – A bit broader in CNS but working on fast-acting neuropsychiatric therapies. Similar to $VTGN in trying to fill unmet needs but still in development phase for most.

h3xpl01t

Hey, love this breakdown — thanks for bringing $VTGN back on the radar! That fasedienol angle is interesting, especially the part about non-sedative, fast-acting treatment for Social Anxiety Disorder. A couple quick questions though: * Did they share any new data on efficacy or just reiterate prior findings at the ADAA conference? * Do you know where they are in the FDA timeline — are we expecting Phase 3 readouts soon or still in mid-stage? * Any word on how they plan to commercialize fasedienol if approved — partner, go solo, or license it out? Also, out of curiosity, how do you think $VTGN stacks up right now against some other CNS/mood-focused names like: * **$MNMD (MindMed)** – Also targeting anxiety but with a psychedelic pipeline (MM-120 for GAD). Higher risk, but also drawing attention for novel mechanisms. * **$AXSM (Axsome Therapeutics)** – Their AXS-05 (approved for depression) gives them a revenue-generating foothold while they explore more indications. Stronger fundamentals but less upside room maybe? * **$PRAX (Praxis Precision Medicines)** – A bit broader in CNS but working on fast-acting neuropsychiatric therapies. Similar to $VTGN in trying to fill unmet needs but still in development phase for most.

twiggs462

I know this thesis may sound completely messed up but drug companies that are working in the CNS space for Anxiety and Depression will skyrocket - the use case scenario is getting really ripe.

Martin_2704

CNS in the spotlight As Newron’s evenamide programme has garnered notable attention, exemplified by its licensing deals to date, we highlight that this reflects a resurgence of interest in CNS in the healthcare sector. In the last 18 months, there have been four multi-billion-dollar acquisitions of biotech players: Cerevel Therapeutics (by AbbVie at a 22% premium), Karuna Therapeutics (by Bristol Myers Squibb at a 53% premium), Longboard Pharmaceuticals (by Lundbeck at a 54% premium) and, most recently (announced during the JPMorgan Healthcare Conference in January 2025), Intra-Cellular Therapies (by Johnson & Johnson at a 39% premium). Of particular relevance to Newron was the Karuna deal, as it focused primarily on the schizophrenia drug candidate KarXT, which was approved by the FDA in September 2024 (with the drug now named Cobenfy). Cobenfy works via a novel mechanism of action, selectively targeting muscarinic receptors M1 and M4 (associated with cognition, learning and memory). The approval was considered a key milestone in the field of schizophrenia, which had been relatively stagnant since the 1950s, since the novel mechanism represents an advancement on the historical dopamine hypothesis of schizophrenia pathophysiology. We note that Newron does not see Cobenfy as evenamide’s direct competitor, as management believes evenamide is differentiated by its favourable side effect profile and the fact that it is specifically targeting durable responses in the TRS patient population, which is not included in the label for Cobenfy. https://www.edisongroup.com/research/pivotal-evenamide-trial-looms/BM-1473/

Yurets44

As part of the event, Sandra Silberman, MD, PhD, Chief Medical Officer of CNS will give an oral presentation titled, “The Use of Traditional Chemotherapy with Activity In the Treatment of Glioblastoma: Novel Formulations of an Anthracylcine & a Taxane That Appear to Cross the Blood-Brain Barrier,” on Thursday, February 20, 2025 at 10:45 AM ET. It might be a long shot but we’ve all been bag holders grasping at straws. Don’t fault me for that.

Powerful_Path8078

For those in CNS already kinda hurts, those not, I would get in now!!! She just hit her low and is slowly going to bounce back. Remember big presentation tomorrow. The big dip came from all the idiots who don't understand a reverse stock split doesn't mean they will lose money

Competitive_Beyond_7

Days still early, volumes still high, just bought more on the dip, who else is on the CNS ride!

Yurets44

This has been a rough start to the week. However, I don’t know if anyone mentioned this company, CNS Pharmaceuticals (CNSP). Looks interesting 🤨

UltraPoss

If humans can develop such a good model with less advanced hardware and less chips, then God knows what they CNS using more advanced chips and hardware and more chips ? I don't see the problem here.

needhelp0911

Hoping to get out of CNS today while I'm ahead... keeping some for the long hold though.

LongTermStocks

**MIRA Pharmaceuticals Clears Key Milestone with Ketamir-2’s Favorable Safety Data** MIRA Pharmaceuticals $MIRA has announced a significant breakthrough in the development of its novel oral ketamine analog, Ketamir-2. Recent safety studies revealed no adverse effects, validating its strong safety profile and paving the way for Phase 1 human trials slated for early 2025. The preclinical findings demonstrated robust safety across multiple evaluations. Cardiovascular and respiratory tests in animals showed no adverse effects, while central nervous system (CNS) assessments confirmed no significant changes at therapeutic doses. A 14-day toxicology study revealed Ketamir-2’s tolerance at high doses, and the drug was also found to be non-mutagenic in an Ames test. “These results underscore Ketamir-2’s potential as a safe and effective treatment for neuropathic pain,” said Erez Aminov, CEO and Chairman of MIRA Pharmaceuticals. The Phase 1 trials will focus on safety, tolerability, and pharmacological profiling, with results expected by Q2 2025. MIRA anticipates launching a Phase IIa proof-of-concept study in late 2025, targeting patients with neuropathic pain. With millions seeking alternatives to addictive pain medications, MIRA’s development of Ketamir-2 represents a pivotal step toward addressing unmet medical needs, supported by a strong financial and strategic position to advance its clinical milestones.

yourgivenname

CNS doesn’t work if you have 150% of a stock owned by institutions. This is not a situation in which CNS is helpful. Especially when consumers are starting to buy more stock of a company that isn’t keen on dilution.

Putins_orange_cock2

These people don’t understand CNS. Look it up. There is a very efficient way to clear excessive short interest. Also, do you think the “shorts” just don’t buy calls as well when they cover? To think a hedge fund wouldn’t you know, hedge? I did by a call when it hit 7ish because the stock is highly volatile, but if you only catalyst is “excessive shorting” then you are dreaming of it doing anything but trading in a channel.

Routine-Courage-3087

$NGENF full disclosure i’m in it too but I really think they’re gonna be big. They’re working on cures for CNS related diseases/injuries like spinal cord injuries, ALS, Alzheimer’s, Parkinson’, etc. Promising results in preclinical trials and currently in clinical trials and waiting to fill up and release results. Positive rumors going around. Very low market cap and lots of room for upward potential like being listed on more platforms like robinhood, clinical trials being announced that is filled, Positive Clinical trial results, announcing clinical trials for different drugs/cures. Results are expected 2025 and insurance companies would pay for a cure like this in a heartbeat simply due to all the costs these injuries cause them and it would save them tons of money long term. The team behind it is experienced and thorough and the scientists namely Dr. Jerry Silver has been working on this for decades. At the very least look into it in depth and read up on it and I believe you’ll agree it’s a solid hold the more you learn about it! Good luck

_Straightshooter

I have a healthy position in a pharmaceutical company: Anavex Life Sciences who’s top line trial data for an Alzheimer’s drug is significantly better and who’s mode of action differentiates itself from the current “MABS” that have been marginally approved or disqualified because they are injections, their patient pool is very specific and limited, and the MABS also can cause adverse brain bleeding, where the “cure” is worse than the disease. Anavex’s Blarcamesine is administered orally in pill form and addresses the root cause of Alzheimer’s (protein misfolding at the cellular level) and a whole host of other CNS- Central Nervous System disorders (Parkinson’s, Multiple Sclerosis, Rett Syndrome, ALS- amyotrophic lateral sclerosis, Dementia, and Epilepsy to give you a sense of the scale that this company’s products should be able to treat. Obviously all these disease specific trials still need to be run but the CNS space is woefully underserved. Anavex has a trial for Parkinson’s ongoing as well as having a more extensive platform-pipeline of pharmaceutical compounds that are currently in development. In summation, Blarcamesine provides a better patient outcome, is cheaper to administer and has multiple uses.

twiggs462

Yes… They had a cash runway to take them through their phase 3 trials into 2027. They have FDA breakthrough status on their lead drug candidate. If you look at their last PR on their website and listen to the conference call, they also have some very good feedback on their functioning unlining during their studies . This company is going to absolutely crush the CNS drug development market. High possibility of being bought out by a much larger player before phase 3 is up.

Former_Librarian_576

Drinking alcohol frequently leads to overstimulation of GABA the main sedating neurotransmitter system. The brain undergoes neuroadaptation as a result of frequent alcohol administration and thus down regulated GABA receptors in the CNS. If an alcoholic suddenly stops drinking alcohol, there is a relative imbalance of sedating and excitatory neurotransmitters. Due to down regulation of GABA, there is now relative excess of glutamate stimulating NMDA receptors. Glutamate is neuroexcitatory, and excessive neurotransmission commonly leads to shaking, and other symptoms of alcohol withdrawal such as seizures, nausea, vomiting, sweating, tachycardia and confusion.

Berbollah

my CNS is so fried by yesterday's DL session, today ill only do machines, i promise no compounds