CRL

Own-Employee9468

Anyone been watching AQST? They dropped from around $6 to $3.50 on 9th Jan. when they disclosed FDA identified deficiencies on a form 483, and have slowly bled down to sub-$3 since then. Was thinking of getting in if it dips on delay or CRL news, top-line PK data looks really good despite FDA concerns and they have $120mil cash to last a year or so.

zbern

So since the BIOSECURE Act was signed into law late last December to shift manufacturing away from foreign firms. I was digging more into this last night. I have found a few if anyone is interested since biopharma seems like a major focus outside of data centers. Charles River Laboratories ($CRL) - they provide essential laboratory models and preclinical testing services for drug companies Bio-Techne Corp ($TECH) - they make the ingredients like cytokines, high-quality proteins, and antibodies that biotech labs use as the raw materials for experiments Stevanato Group ($STVN) - they make the 'vessels.' specialize in glass vials and syringes Just a thought if anyone wants to research or get exposure without taking the risk into drug makers themselves. Boring companies but kinda like 'plumbing plays'

adifferentGOAT

How do you feel about QURE in light of the FDA’s change of course with its reasoning for ATRA’s 2nd CRL, that the single arm design is now inadequate.

tocompose

There is a chance AQST doesn't get the labelling done by the 31st which makes it not a sure thing but rather a coinflip whether they can get it done by then or not. So a coinflip for no CRL or a CRL. A gamble

cloud_sec_guy

Here's a nice animal testing stock that is doing well: CRL

Red_Devils_2402

Dude It’s dead. They received 3rd CRL. It means a new phase 3 clinical trial, which would cost millions and more than 2+ years to complete. Move on.

derivativesmarket

CRL Charles Rivers Labs.. deals in lab animals. Doesn’t get darker than that.

Celestial_Surfing

“In the CRL, the FDA noted that the additional mechanistic and natural history data information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application, however the FDA has not indicated what type of confirmatory evidence would be acceptable.” Pretty fucked up IMHO.

stevenryl866

OTLK - another CRL, lucky me that I have small amount in it. I have low confidence they will get the approval, just buying in for the ride

Kelmos_90

Today your play is OTLK. If it get CRL you will have less play money. #gambling

DataExternal4451

OTLK fell from \~2.6 on 25th August due to receiving Complete Response Letter (CRL). They have resubmitted and the PDUFA goal date is now 31st December. They are approved in EU and UK so there should be significant impact if they get approval for US

ankur1088

Watch out for MIST MIST (Milestone Pharmaceuticals) is awaiting a crucial FDA decision for its nasal spray, CARDAMYST (etripamil) for PSVT, with a new target approval date (PDUFA) set for December 13, 2025, after the FDA accepted the company's response to a previous Complete Response Letter (CRL) addressing manufacturing issues, not clinical concerns.

IU_leejieun0618

Likely to see the result at this Friday morning. Last time the CRL they announced at 6am ET

ismell_likebeef1

That’s a very good point. Why roll over and die without one last attempt while they can. If they do receive a CRL they may use EU sales and patients as the study instead of having to pay and run a new study in the US, so maybe it won’t die at all… hopefully 🤞

ismell_likebeef1

Do you think that they are just resubmitting as fast as they could with some additional data requested from their meeting with the FDA and hoping that it will see approval? I can't see why the company would resubmit so quickly after a meeting with the FDA if they know it is going to recieve another CRL, if it fails again it will send the company to an early grave.

Ga_glovo

I lost 70% but did not sell - today it is 40% gain - you should not sell, CRL was a great opportunity to buy more...

BeneficialSort9477

About time to jump into $MIST, superb price right now PDUFA in Dec, last round CRL with only CMC issues, highest approval likelihood that we've seen in a while

Gydvinn

Its definitely luck. You can yolo anything and have 50% chance of losing or making money. The DD you do on pennystocks doesn't actually matter if companies under deliver. Most biotech don't get FDA approval even if their med is proven and would save thousands of lives. Slightest problem with their manufacturing and they get CRL. Look at FBIO.

Orange_Codex

There's a chance they deny the drug, but I wouldn't say it's huge. There are multiple anti-psychotics on the market, brilaroxazine is at least as effective as any peer, and it has far fewer side-effects. Unfortunately, FDA roulette is part-and-parcel of biotech. If they are rejected or receive a CRL, they go down 50% in a day. If they are accepted or publish good trial data, they go up 70-1,000%. It's just the nature of the game.

Orange_Codex

Took a small position on RVPH. Not my favourite biotech stock. Overall efficacy data for brilaroxazine is similar to competing antipsychotics (aripiprazole and lurasidone), while positive safety benefits might be illusory (due to the short duration of Phase II trials). However, barring a CRL, there is likely to be well-presented good news today.

Electronic_Pay_5674

Minvera’s CRL and not meeting primary efficacy? Potential partnership? You tried to do a detailed DD but seem to omit important details.

Orange_Codex

>I think no risk for this company Er, I'm extremely bullish but there is *definitely* risk. Firstly, there's a risk of dilution: 20% of the float is in warrants priced at $0.83. Secondly, the company might become insolvent (trials and approvals are crushingly expensive). Thirdly, issues unrelated to the drug - like a CRL - might delay approvals, which could be fatal amid cash flow issues and will definitely tank the share price (look at what happened to FBIO). Fourthly, the lead drug might be outperformed by a competitor during development. So far this looks unlikely but it's not impossible. Fifthly, there might not be an economical commercialisation pathway: INTS therapies might command too high a price, need too much rare expertise, or face too many hurdles with insurers to capture a viable portion of the TAM. These are organised from most likely to least likely, in my opinion, but for practical purposes can all be filed under: "who knows?" Maybe INTS has discovered a general application wonder-drug that can carry the price to $50 per share. Maybe they don't relist by December, a reverse split causes algos to flee, cash crunches spook the market, and surprise safety concerns put the nail in the coffin. Who knows?

grkblood13

CRL for quick gains since it took an 8% dump yesterday after it BEAT earnings.

plannedgravy

CRL puts

oquido

$NERV, PLEASE STAY away from this garbage. It's a biotech with a failed science, and had no meaningful results from their failed Phase 3 study. They need to completely re-do the phase 3 study which took them 3.5 years previously (Which NDA initially "rejected-to-file", but accepted via an appeal, then received CRL eventually). $NERV is a dead company. Dead science, now trying to scam retail investors. STAY AWAY

Phyrodox

Posted yesterday, but MIST is a great option for those into swing trading. Very high likelihood of FDA approval on the 13th December after addressing CMC issues causing their CRL. Unmet clinical need in a rare pathology. I've got 2,500 shares and picking more up on this week's dip. NFA

If_only_one_listens

A CRL I tracked took six months until a new review/approval meeting—without a government shutdown. I doubt it, but maybe the drug's fast track status changes this timeline. A date will likely be announced this week or next (within 30 days of the request). --- TLDR: Fly survives until April. Calls cooked.

DontDoDrugs55

Yeah they have the price target at like $60 it's just a bitch waiting for the FDA to approve this drug. I think I'll be holding this into late next year. The FDA issued a CRL because there was some issue with the manufacturer, but didn't have any concern with the drug...So I'm thinking it should be an easy road to approval if they just change the manufacturer...But still takes forever.

No_Weakness_5888

Well, average price estimate is 50$, I guess 10x is a great upside.  Also, it is likely the company gets the approval. The CRL has only CMC issues and nothing regarding the drug, so I think the rejection in Dec is an unlikely event. Or what is your opinion?

Gydvinn

I generally don't invest in biotech but let me tell you this, it doesn't really matter if everything goes smoothly as announced for the trials (which almost always it doesn't), if FDA finds a little bit of something that doesn't comply with their regulations, its an instant CRL. So think wisely. Same happened with FBIO. It was a proven med which prolongs life expactancy by 14 years but they still got a CRL.

Outrageous-Habit-547

**One issue from the CRL -** **Deleted audit trails / missing eCOA records:** This one is major. If records and audit trails were deleted by the vendor, FDA cannot confirm whether endpoints were altered, back-entered, or otherwise modified. Even if Applied had “paper backups” or video evidence, the absence of a secure, traceable electronic record means the trial’s **primary outcome integrity could be compromised**.

Outrageous-Habit-547

But given that the errors were data errors, thus compromising the authenticity of the results, you don't think the FDA will require another trial to confirm the drug prior to approval? Or do you think that they could do enough to show that the compromises were clerical and not skewing data and thus another trial does not need data before approval? To me this is the key to knowing what the FDA will do. If they are happy with the answers to the CRL and think Applied has addressed the issues and shown that it was mostly just administrative issues or if it was errors that affected the outcomes.

Mark_of_Divinity

Uh..\~40 % confidence to the strength of their evidence, given what’s publicly known so far. Short answer: **no, it’s unlikely to be approved** in its current form — there’s significant evidence that the FDA has already rejected a version of it, and there are serious concerns about trial conduct. Here’s what supports that: * The FDA issued a **Complete Response Letter (CRL)** rejecting govorestat for **classic galactosemia**, citing “deficiencies in the clinical application.” [NeurologyLive+2Fierce Biotech+2](https://www.neurologylive.com/view/fda-issues-crl-govorestat-application-classic-galactosemia?utm_source=chatgpt.com) * The FDA also flagged problems in trials of govorestat: • A **dosing error** where subjects got \~80 % of the intended dose due to labeling issues. [Fierce Biotech+1](https://www.fiercebiotech.com/biotech/applied-therapeutics-trial-conduct-questioned-fda-warning-letter-days-after-rare-disease?utm_source=chatgpt.com) • Deletion of electronic data by a vendor, raising questions about data integrity. [Fierce Biotech](https://www.fiercebiotech.com/biotech/applied-therapeutics-trial-conduct-questioned-fda-warning-letter-days-after-rare-disease?utm_source=chatgpt.com) * The company is still in discussions with the FDA about regulatory strategy for the **CMT-SORD** indication and has *not* yet established a clear submission path. [Applied Therapeutics+2Stock Titan+2](https://ir.appliedtherapeutics.com/news-releases/news-release-details/applied-therapeutics-provides-update-following-meeting-fda?utm_source=chatgpt.com) * The company’s own pipeline info claims govorestat showed reductions in sorbitol and correlations with functional outcomes in the CMT-SORD trials. [Applied Therapeutics](https://www.appliedtherapeutics.com/pipeline/govorestat/?utm_source=chatgpt.com) So, given the CRL, trial concerns, and regulatory pushback, the risk of rejection is high unless they fix those issues.

mamegan

I was pretty disappointed about the CRL but knowing that it’s manufacturing and not the drug gives me some confidence. If they can get their manufacturing correct, it could be huge

stevenryl866

FBIO - tanked due to FDA given them CRL. Manufacturing issue, and it FDA typically provide another response in 6 month +/- after the issue resolved. Looks like a good dip to buy some and hold. Manage your own risk, and I did not buy before the dip, I bought in when it dip

slinkboss22

FBIO got a CRL (no approval) just fyi

Full-Obligation-9376

News hit CRL for delay of approval

ProudKnee2755

The stock is currently at $3.32, which is lower than before but still reasonable. There’s no official information anywhere about an FDA approval or a Complete Response Letter (CRL). Hopefully, we’ll have a clear answer tomorrow. It seems part of the recent price drop was driven by investor panic over the lack of an announcement, assuming the FDA might have rejected the NDA. If that were the case, however, it’s unlikely the stock would have rebounded from $2.55 back up to $3.32.

ProudKnee2755

The stock is currently at $3.32, which is lower than before but still reasonable. There’s no official information anywhere about an FDA approval or a Complete Response Letter (CRL). Hopefully, we’ll have a clear answer tomorrow. It seems part of the recent price drop was driven by investor panic over the lack of an announcement, assuming the FDA might have rejected the NDA. If that were the case, however, it’s unlikely the stock would have rebounded from $2.55 back up to $3.32.

slinkboss22

What is a CRL

Bluesquare9

People think it’s a CRL but no confirmation… I just saw that on X… who knows.

DueDiliPence

**THIS IS AN ENTIRE FABRICATION** "In October 2024, the FDA approved ORLYNVAH." **Reality:** The FDA did **NOT** approve sulopenem (ORLYNVAH).Iterum Therapeutics received its **second** Complete Response Letter (CRL) from the FDA. **A CRL is a rejection**. The FDA stated that more data would be needed to approve the drug. **Head in the clouds unrealistic assumptions** about market penetration and you **dishonestly minimise the downside risk** the stock will not stay "flat" in a failure scenario, this is entirely illogical. Sucks to be you with your bags of copes and dreams

xeemyy

They actually have approval decision awaiting after a prior CRL though. End of Q3 was listed for the release of the news.

Cultural-Hamster-476

This company has gotten a CRL before for the same reason Srrk did and it didn’t have to do anything with the drug or treatment itself. The lab or building failed inspection in both cases. Both have high probability for approval but you never know. I have 300k on it 🫣

leomeng

SRRK got a CRL for a manufacturing site issue (not drug failure). Gonna be down huge. If you are patient you can buy the dip.

Business_Concert9317

I’m heavily invested but down 50% after CRL. I was hoping to be in the money by now. Some sleepless nights but hopefully they get it right this time 

poopinmypantss

The IV on CAPR options expiring tomorrow is 350-450%. Pretty sure tomorrow they’ll be releasing a statement detailing their path forward after they were issued a CRL by the FDA two months ago. Could potentially make money on either side, down or up.

RunningRobert1980

Thank god I avoided that disaster, This stuff is a little more safe since they already have the data, the FDA has told them the data and safety were good, and they got a CRL for Manf. which has been solved, plus 75M on approval

OyyBrent

Ok here’s the AI response to these ridiculous price targets just to be objective here : Here are the main issues: ⸻ 🔹 1. “No dilution risk until 2028” is unrealistic • The DD claims Spero has cash until 2028 and won’t dilute. That’s not accurate. • Their last 10-Q showed a limited cash runway, extended by GSK milestones — but not enough to fully eliminate dilution risk. • Small biotechs almost always raise more capital before commercialization, even with a partner, especially when relying on royalties (which are low %). • Expect additional equity raises in the 1–2 years post-FDA approval. ⸻ 🔹 2. Overstating royalty economics • The DD suggests royalties could hit $190M/year if sales beat $2.7B. That’s misleading: • The royalty tiers are low (low single digits to low double digits). • For SPRO to see $190M/year, Tebi would have to sustain multi-billion sales at the high royalty tier — which is highly unlikely for an antibiotic. • Realistically, royalties would probably be in the $30–60M/year range at peak. • That makes the “FDA approval = $7–9 stock” assumption too aggressive. ⸻ 🔹 3. Overinflated buyout thesis • GSK holding ~16% is not a guarantee of a buyout. • Large pharma frequently partners without acquiring — especially in antibiotics, a space known for poor commercial returns (Melinta, Achaogen, Paratek all struggled). • Antibiotics have been historically weak M&A targets, even with strong trial data. ⸻ 🔹 4. Ignoring FDA label risk • FDA approvals for antibiotics often come with narrow indications, which can cut revenue potential. • The DD assumes a broad label for cUTI, but the FDA could restrict usage to ESBL-E or resistant pathogens only, reducing uptake. ⸻ 🔹 5. Valuation math problems • Market cap is ~$110M now. • The DD’s price targets ($7–9 approval, $14–21 buyout) imply >10x upside, but that ignores: • Near-term dilution • Modest royalty flows • Narrow label risk • Competition (new IV/oral agents are in the works, plus generics will pressure pricing) • A more grounded post-approval valuation might be $3–5/share near-term, drifting lower as dilution sets in unless sales surprise to the upside. ⸻ 🔹 6. Misleading claim about “no clinical risk” • The trial was stopped early for efficacy — great news, but it doesn’t make approval guaranteed. • FDA previously issued a CRL for Tebi (2022). They’ll scrutinize the new dataset carefully. • Manufacturing and resistance-pattern questions could still trip them up. ⸻ ✅ Bottom Line The DD oversells SPRO as “safe” and massively undervalued. What’s wrong with it is mainly: • Overstating GSK’s commitment → implies buyout is inevitable. • Overstating royalty value → ignores real-world antibiotic pricing. • Understating dilution risk → cash needs are not solved through 2028. • Assuming broad FDA approval → label could be narrow. • Unrealistic price targets → ignores past antibiotic failures. SPRO does have a real catalyst and backing, but future share price is more likely to see a pop into the $3–5 range around FDA approval than the $7–21 that DD projects, unless something very unexpected happens. ⸻

RunningRobert1980

yeah I am pumped I think they took care of the CRL, so nothing stopping us from approval!

RunningRobert1980

Nope it when they did an offering, Mar was the CRL

figlu

CRL

Reno911-07078

The answer is yes! Coverage initiated by Wells Fargo a few days ago w price target of $4. CRL was related to the manufacturing facility inspection, which I believe they switched to an already inspected/approved facility, as well as seeking more info on nitrosamine impurities, which they provided. I’m hoping for early approval!

stockratic

The article in the link says June 28, which did occur. That's when they got the CRL.

stockratic

You are welcome. My favorite is NRXP, bc I love their mission. I made a comprehensive post on this sub yesterday, which includes my previous posts within. Biotechs are wild. Some, like TNXP which recently went as high as $60 or so days before FDA approval (MC $550M) drops to $27 a couple of weeks after approval ($240M MC) bc they are starting commercialization. Good buy point and hold in my opinion. I think TNXP and NRXP have pretty similar TAM s in terms of number of people suffering from their applicable disease/indication. NRXP’s MC is $55M and they are close to getting a PDUFA date set with the FDA. It it were to act similar to TNXP (and some other biotechs), NRXP’s shares could 5x prior to approval. But after FDA approval (which has a very high probability as you will see) since they will own many clinics to begin delivery of their treatment, the share price could keep going up. Similar in certain ways to UNCY. All 3 companies did r/s that hurt then-current shareholders, but it is a necessity so often in biotech as you may know. UNCY’s MC is about $74M now. I think it should similarly increase to a MC that is 3x to 5x the current before the PDUFA date, and end up with a MC far less than TNXP’s was at that time and a little above what TNXP’s is now after their drug was approved. Especially true since UNCY got a CRL from the FDA and the drug had no issues, which to me is like a pre-approval and greatly derisks their drug/asset. This comment probably deserves a short post. What should happen and what does happen can always be different. But, the only thing I try to do is research the facts hoping they are right (esp. using AI to help), and then draw comparisons.

stockratic

NRXP, UNCY, CAPR (the latter two have FDA CRL PRs coming this month, with good news)

cutiesarustimes2

How do biotech traders breakup They issue their girlfriend a CRL

BiotechJoy

A combination of things: 1. The nature of their business is quite complicated (multiple private subsidiaries, some of which have out-licenced parts of their pipeline) making it hard to value at first glance. 2. One of their biggest subsidiaries was Checkpoint, which got hit with a CRL in late 2023, which set back one of their big revenue sources. They later got approval in 2024 and were sold off this year which bolstered the balance sheet, but I think confidence took a bit of a hit with the delay. 3. There are 2 classes of shares, the Preferred shares pay a perpetual dividend (costs about 600k per month) but it has been paused since last July. While these distributions are paused, the company can't raise cash via offerings under S-3. They also have some debt. 4. Biotechs under 100M mc just don't get a lot of love! However. This all said, the number I gave was net of debt. They have bolstered their balance sheet, and if CUTX-101 is approved and the PRV is awarded, that is a huge income and will make it very likely for FBIOP dividend to be restored (it is also a requirement that the debt is paid off via proceeds of the PRV sale). So this would significantly improve confidence, and also (the bit I didn't mention) buy a significant amount of time for DERM's launch of Emrosi to gather pace and tip them into profitability (projected to happen later this year). I think upon achieving a tidier capital structure and more cash in the bank, the market will take a more appropriate valuation.

AbhinaavS

I'm so sorry, guys. One thing I have noticed though, is that right after the initial massive dip due to a CRL, the stock rebounds by a fair bit. Otlk just did. Repl also went up by 100% after the initial drop. So even if it might feel like taking out the money right then is the right move, keeping it a bit longer (if not adding more to bring the avg down) might help.

stevenryl866

Scoop bottom if you really did the DD, this is my 2nd scoop the bottom from OTLK. They got the CRL early this year and I scooped the bottom reversal play hehehe

SjalabaisWoWS

> ISELIN, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA **cannot approve** the application in its present form for the treatment of wet age-related macular degeneration (wet AMD). The stock is crashing. Is this good news?

stevenryl866

OTLK - my prediction was correct ! 2nd CRL! Anyway scoop some bottom, should recover >1.2

Wooden_Customer_8610

Fyi CAPR already got CRL not sure why that's on this list. Love how it says 58% of approval yet it already got declined lmao

Kdean21

wait a second here: the FDA will basically qualify it for an approval based on the long term results review - yes it will be a positive catalyst but it probably won't be a accelerated approval. check out my research this to me is more clear guidance: * **December 2025 – January 2026** (Potential PDUFA Date for Priority Review): If the FDA grants priority review (6 months), the PDUFA date for a final approval decision could fall in this window, based on the June 26, 2025, NDA submission. Approval would be a major positive catalyst, potentially enabling a 2026 commercial launch, while a Complete Response Letter (CRL) or delay would be negative. The Breakthrough Therapy designation for vaping cessation increases the likelihood of priority review. * **April 2026 – June 2026** (Potential PDUFA Date for Standard Review): If the FDA assigns a standard review (10–12 months), the PDUFA date would likely fall in this period. Similar to the priority review scenario, approval would be a significant positive catalyst, while a CRL or delay could negatively affect the stock price. * **H1 2026** (Initiation of Phase 3 ORCA-V2 Trial for Vaping Cessation): Achieve plans to initiate a Phase 3 trial for cytisinicline’s vaping cessation indication, following a successful end-of-Phase 2 meeting with the FDA. The trial’s start, contingent on funding, could be a positive catalyst, especially given the FDA’s Breakthrough Therapy designation for this indication. Yes there will be a run-up Monday...but will it blast past $5 is my real question. But I don't see any major setbacks for the rest of this year....so it should have a bluish trajectory.

stevenryl866

PTCT - received CRL from FDA, price should tank! Make sure to scoop some share in the drop (if any). Please note this ticker not penny pricing. They have in between 700mil-1.1bil of cash. 8.30 resume trading.

stevenryl866

They got CRL and the price tanked! As for now, it’s seems hype pump. Expected catalyst date from FDA on 27th. Beware on the dilution. I was in then the price tanked, and made profit

stockratic

UNCY and NRXP have small MCs and will 10x. UNCY got a clean Complete Response Letter (CRL) from the FDA except for needing to fix a third party manufacturing contractor issue. Meeting with FDA and after 30 day written report of the meeting by FDA (here in Q3), will get a new PDUFA date set. Their drug lowers the number of pills a dialysis patient must take by up to 4 times. 79% of the patients in the trial preferred their drug. NRXP is readying for a pretty amazing setup. It is my favorite bc they address a national health crisis. I made a detailed post earlier this week (where they recd Fast Track designation for NRX-100 and posted on the same day an article stated that Wall Street was beginning to take notice).

Prestigious-Ant-7210

Worth noting that they previously had a CRL purely due to manufacturing concerns which is often a very good sign for approval upon resubmission

Prestigious-Ant-7210

I’m in on UNCY, CRL purely due to manufacturing concerns derisks their next application imo. This one looks interesting too, what do you make of their high debt/low runway?

Phyrodox

Just be wary. Vinay Prasad has been reinstated as the head of CBER at the FDA. His track record so far is grim reading and rumours he personally intervened on REPL to cause a CRL. I was bullish on PGEN but with Prasad in the frame I won't be risking FDA shenanigans for a while

Prestigious-Ant-7210

MIST, pretty de-risked PDUFA date of December 13th. Hammered by dilution (so no more until the PDUFA) + getting a CRL solely based on manufacturing rather than efficacy in their first submission (historically this is a great sign for approval on the second submission). Current standard of care for their treatment is going to the hospital, so limited competition and around a 2 billion dollar potential market. I’m accumulating at around $1.5 and am planning to continue until the PDUFA date

Normal-Phase-1252

CRL had an earnings surprise of -362.66% and yet you did not take profits at open when it was up 13% for no reason?

Best-Bodybuilder9015

Initial FDA review and setback Outlook Therapeutics initially submitted a Biologics License Application (BLA), but the FDA issued a Complete Response Letter (CRL) in August 2023. Key issues cited included deficiencies in chemistry, manufacturing, and controls (CMC), preapproval inspection findings, and the need for additional confirmatory clinical data

stockratic

Keep in mind they are required to report a CRL in an 8-K because it is a material event.

North_Ad_4609

Okay at least Q2, because MDUFA, reviews range from 90-180 days. The ceo acknowledge there has been communication with the fda but did not reveal anything else. There must have been a rejection or something along the lines of CRL, I am not very well versed with 510K fillings communication. This is not within the time frame for the review of 510K set for MDUFA. Just a little shady for me. Also FDA approvals are not guarantees by any means. I sense rejection coming here. Just my 2 cents.

Avish_Golakiya

I tends to with 70-30. 30% high risk high rewards and the rest commercial biotechs. Also I some time buy 52-week low on CRL basically FDA rejection if the reason is not scientific rather operations or CMC

Prestigious-Ant-7210

I’ll also add one, I think MIST is very undervalued. Stock took a beating due to getting a CRL + dilution to keep funding up, but the CRL was only due to the manufacturer of the drug, not anything to do with the drug itself which de-risks it some in my head at least. Also a decent sized market where the only current treatment is going to the hospital. Their new PDUFA is December 13th and I think $1.50 warrants will keep the price around there so plenty of time to accumulate

BaronDavis12

Crazy price movement with $REPL. -76% day last week after CRL from FDA. +72% premarket right now 

Phyrodox

Been on my watchlist all week. Why oh why I didn't buy the dip after the REPL CRL is beyond me. Sometimes I need to trust myself more

Phyrodox

Annoyed at myself for not buying the dip when REPL got a CRL (probably because I was too busy being annoyed at myself for not taking REPL profits before it got slammed)

Avish_Golakiya

quick follow‑up to keep things transparent, even after saying I was sidelining for the rest of July, I did sneak back in with a couple of small trades, mainly topping up PHVS on the pullback and grabbing a starter in CRNX ahead of the data hold. Nothing huge, but enough to nudge July’s final gain to just over **23 %**. Promise I’m really parking it now and focusing on the August PDUFA slate; just didn’t want anyone thinking I’d gone radio‑silent while still trading. Also got it REPL, CRL news now sitting at $3 avg.

haze_from_deadlock

CRL up bigly today. Don't invest in a company that's metaphorically radioactive dogshit when you could invest in a company whose business model is actual, literal radioactive dogshit

Chivalrousllama

Iovance’s primary competitor (Replimune, REPL), just received an FDA rejection (CRL) for their competing drug. Aside from the high short interest, Iovance losing its only drug competitor may be the spark to ignite the keg.

Chivalrousllama

Along with Replimune’s CRL

AbhinaavS

Hahah. I'm good, just pretty surprised at the CRL. On to the next one, ig

MitchCurry

>The CRL indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised. Brutal. Their balance sheet and cash flow burn gives them maybe 2 more years of runway but unless they have something else in the pipeline that's promising, not sure how they don't just close up shop.

BaronDavis12

$REPL getting destroyed premarket. Got a CRL (complete response letter) from the FDA. $12.32 to $2.99

Nusanss

It warms my heart :D UNCY play didn't work out as well, we got CRL from the FDA and I got some messages from people who lost a bit and it made me question, should I post these DD\`s or just keep doing my own thing... Even though the DD was spot on, it was always a gamble with limited downside and a massive upside.

_TrueSelfGlow_

Biotech breakout play or just another dead cat with a CRL collar? Watching $ZVRA like it’s a Phase 3 endpoint. Volume’s real, float’s tight — if we see EU filing confirmation, it could moon. Otherwise… rug city. Calls 7/26, $15 strike, lotto ticket vibes

AbhinaavS

Me too! But I see a CRL as unlikely, considering RP1 already got fast tracked by the FDA and received priority review and breakthrough therapy designation.

Phyrodox

Got a position in REPL at 9.5, only added a starter before it started rising. Wish I bought more, but happy with it's positioning before the PDUFA, gives me some buffer if a CRL is issued and price dumps

Ga_glovo

I am in the stock since November. They are very near approval. Next PDUFA date is 13 December. Today they announced 52m dilution (that is why the stock cratered) and renegotiated royalty of 75m if approved on 13 December. The drug is safe and effective (no FDA complaints). CRL issue is a minor thing and will be solved. In my view, now they will be full of cash and further dilutions are not likely - only patience is needed (obviously, people do not have it and want fast money, as soon as possible). After CRL (obviously no one read it, although it was mentioning only technical issues and was not a rejection) the stock cratered 70% with no reason, and it was a gift. I believe Cardamyst will be approved on 13 December (at least 80% chance) but even more, the spray is much more efficient with Afib, which is a bigger market - have no doubt Phase 3 will just confirm 1 adn 2 Phase success - after that only sky is limit as USD 1bn in potential revenues (combined PSVT and Afib) can not be valued at 85m + incoming approval in China and royalty/fees from that market.

Nice-Path8600

Company announced that the FDA accepted their CRL (which is good news): https://investors.milestonepharma.com/node/9976/pdf But at the same time, they announced another public offering (so… dilution for current shareholders :/ ): https://investors.milestonepharma.com/news-releases/news-release-details/milestone-pharmaceuticals-announces-proposed-public-offering-1 That’s why the price tanked today. Really wish I had sold yesterday, didn’t realize they were running low on cash and would go for a public offering.

Ethto

I’ve watched **$1.5 million in unrealized gains disappear since this post**. That’s not easy to stomach. But honestly, my financial loss feels small compared to what really matters: the delay in bringing hope to families living with Duchenne muscular dystrophy. This wasn’t just a trade to me. It was a belief in a therapy that could give kids more time—time to breathe easier, to hold onto strength a little longer, to live a little fuller. Deramiocel isn’t just another drug on a spreadsheet. It’s a shot at preserving heart function in boys whose bodies are failing them far too young. I respect the FDA’s role and the need for rigorous data. But celebrating this setback? Cheering the CRL like it’s a win? Behind this company are scientists pouring their lives into something meaningful, and families holding onto the possibility of something—anything—that could slow down the heartbreak. So yes, I’m down big. But my pain is paper. The real pain is the one that’s been prolonged for parents watching their child fade without options. **And that’s exactly why I’m still long.** Because I believe in the data. I believe in the team. I believe HOPE-3 will deliver what the FDA needs to see. And most of all—I believe these families deserve a shot at a different ending. I'm not walking away from that.

Logical_Affect1883

well Vinay just Un-Schrodinger'd the CRL....

Market_Monkey_

Honestly, I think everyone's focusing too much on the optics and not enough on the underlying pathophysiology here. The FDA’s cardiorenal division has been notably conservative lately, yes, but the absence of an adcom could just as easily signal internal confidence. Verdun’s exit is noise unless you believe she was singlehandedly steering policy, which seems unlikely given how Vinay operates. I wouldn’t call it a 50/50 shot; more like Schrödinger’s CRL until we get real clarity.👀

Logical_Affect1883

You are correct on the cancelled ADCOM .... that screams 50/50 shot. I think VInay would've CRL'd before he fired Verdun ( who has a history of butting heads....though she was on point with Elevidys and disagreeing with Marks) If it is CRL it'll be a C1 and bump in the road ( and OP's net worth ... ).

IceBearLikesToCook

As a biotech person, I have to step in here and say you should sell. A cancelled adcom on an iffy dataset in this FDA cardiorenal unit screams sell. It is more likely than not that this will receive a CRL. This is like playing Russian roulette with five loaded chambers.

tommyjohnagin

Also thinking about taking a long position on CAPR. I have a weight towards CRL over any form of approval, but the implied odds seem worth it. I've been trying to figure out though, what did you make of the cancelling of the ad com and suspension of Verdun. Markets clearly seem to think quite bearish, and the bear hypothesis of Prasad and his new CBER demanding an increased evidentiary standard seems to fit nicely. I don't know if I completely buy it though, for other reasons. Do you have any thoughts?

Ingo2021

Unicycive Therapeutics (UNCY) did not receive FDA approval for its New Drug Application (NDA) for oxylanthanum carbonate (OLC) on the anticipated Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. Instead, the company announced on June 30, 2025, that it received a Complete Response Letter (CRL) from the FDA. The CRL cited deficiencies at a third-party manufacturing vendor as the reason for non-approval, specifically issues related to current Good Manufacturing Practice (cGMP) compliance at a subcontractor, not the Drug Substance vendor. Unicycive has responded to all FDA inquiries and has requested a Type A meeting with the FDA to discuss next steps. The company has also identified a second manufacturing vendor to address the issue. No further approval decision has been reported as of the latest updates.