CRL

sunnythehamster

You haven't discussed the key issue here - whether seralutinib will be approved by FDA and will it be commercially successful Primary endpoint - missed. Even if it didn't miss the p value, the effect size is likely not clinically meaningful. Missed stat sig on most of the secondaries. The market competition all had much bigger effect sizes on the same primary or showed a big difference on harder endpoints. The PH-ILD program is on pause. The drug had a high rate of discontinuations and a liver toxicity signal. It can't hold a handle to sotatercept. It regained the worldwide rights because it's larger pharmacies partner tapped out and pulled out of the agreement. I think this is going to get a CRL, but you never know with a rare disease with high unmet need. Even if it gets approved I don't see how it can compete with the other drugs on the market which blow it out the water

imma_rage_quit12

$grce I expect a fda CRL meeting PR in the next 15 days, expecting it to go up to $3 on this PR(if not from that then $3 on resubmission news). Very thinly traded and not much volume so keep that in mind, but a legitimate company and also has been holding price very stable past few weeks.

stevenryl866

UNCY - possible CRL? -16%

Upstairs_Position651

You casually brushed over "they expect to receive a CRL" like it's a minor speed bump.

No-Example-5107

Bought some Outlook Therapeutics (OTLK) today. Today the company's announcement that the **FDA has accepted its resubmitted Biologics License Application (BLA)** for **LYTENAVA™ (bevacizumab-vikg)** as a treatment for wet age-related macular degeneration (wet AMD). FDA acceptance means the application has passed the initial filing review and will now undergo a full regulatory review. It is not an approval, but it is a necessary step toward one. The drug had previously received a Complete Response Letter (CRL), so investors were waiting to see whether the FDA would accept the resubmission. Acceptance reduces a major regulatory uncertainty. If approved, LYTENAVA could become the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases, which represents a significant commercial opportunity. It has a 60-day FDA review clock, and a good chance of getting approved, perhaps in the 60–80% range (ChatGPT estimate). I expect it to go higher in the next couple days.

No-Example-5107

Bought some Outlook Therapeutics (OTLK). Stock is up about 30% today. The catalyst driving [**Outlook Therapeutics (OTLK)**](https://ir.outlooktherapeutics.com/?utm_source=chatgpt.com) today is the company's announcement that the **FDA has accepted its resubmitted Biologics License Application (BLA)** for **LYTENAVA™ (bevacizumab-vikg)** as a treatment for wet age-related macular degeneration (wet AMD). FDA acceptance means the application has passed the initial filing review and will now undergo a full regulatory review. It is not an approval, but it is a necessary step toward one. The drug had previously received a Complete Response Letter (CRL), so investors were waiting to see whether the FDA would accept the resubmission. Acceptance reduces a major regulatory uncertainty. If approved, LYTENAVA could become the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases, which represents a significant commercial opportunity. It has a 60-day FDA review clock, and a good chance of it getting approved, perhaps in the 60–80% range.

housekeyslow

Phase 3 is already banked.  PIVOT-PO hit its endpoint and got stopped early for efficacy. The approval rate on a Class 2 resubmission is a much tighter, higher distribution, especially when the resubmission directly cures the original deficiency. The 2022 CRL wasn't about efficacy or safety. FDA wanted a second adequate, well-controlled trial. PIVOT-PO is literally that trial. So the "if" is real. You're pricing trial risk that's already off the table. GSK owning the NDA and paying the $25M resubmission milestone is them voting with capital, not a press release. Residual risk here is label language and timing, not a binary reject.

smirk79

The shape that matters The distribution (the SVG) is trimodal and the eye-opener is that the mass sits left of $3. P(below today's price) ≈ 56%, P(≥$5) collapses to ~9% (versus ~48% in my ungrounded first pass), and the ~15% chance of a 50%+ loss is unchanged and ugly — that's the CRL branch, where rescue-financing dilution compounds the loss. The bull's $5–7 target lands in the ~5–9% right tail, not the base case. So what would I actually believe? Three things, in tension: The drug will very likely get approved. The bull is right about that, and right that the GSK structure is elegant (no salesforce to build). The stock is roughly fairly priced at $3, because the market has correctly absorbed both the high approval odds and the limited-use label that caps the commercial story. This isn't a mispriced lottery ticket; it's an efficiently-priced one. The real edge, if any exists, is entirely a bet on label breadth — the single variable that swings fair value from ~$2.69 (narrow) to ~$4.54 (broad). If you have a differentiated view that the final label will be broader than the FDA's "limited use" signaling suggests, that's the thesis. The milestone-counting and reverse-merger narrative is noise by comparison. The honest read is that the Reddit author did real homework but made the classic error: counting gross milestone caps and assuming a commercial-scale label, when the regulatory paper trail points to a de-risked approval of a deliberately narrow drug. Those two facts roughly cancel to "fair value."

ankur1088

OTLK check what was the price on December when FDA issued CRL rejecting the application With yesterdays appeal acceptance price is bound to increase at least to that level till approval

stevenryl866

OTLK - I’m in for 2nd round, it should goes up progressively and price likely between 1 or 2 while waiting for them to submit and pending FDA outcome. After multiple CRL, hopefully this is final and they will get approval. If it does, we may see 4-5 ?

Clean_Reference_9927

It was supposed to go up and it will eventually bounce back. The manufacturing with the plastic in the drug was messed up so they got a CRL.

FreeformSensei

I agree, biotech can be very volatile and high risk. I have a very high amount of confidence in CAPR getting FDA approval for Deramiocel, but the chances of a CRL are not 0%. If the FDA rejects Deramiocel, CAPR will crash hard (over 80% imo). I’ve invested as much as I’m willing to lose

King_Eboue

Really good post and agree that XERS is an easy long. What do you think 6-7 months later? I'm yet to start my position but just wanted to know if you had any updated thoughts, e.g. on the CORT CRL, expectations for 2026 revs

Orange_Codex

If they get a CRL I'll take all the hugs I can get. If they get a buyout, you'll have to climb a trellis of alternative goth models up to the observatory deck of my yacht.

Orange_Codex

Probably. I'd have bought more already if it weren't for macro shenanigans. But you can never be entirely sure with biotech. SLS could quite literally cure death and faulty wiring at a supplier plant would land them a CRL.

Wide-Tie-4477

I lost around 100k in one day few years ago. Went way too big into a biotech company and this bitch got a phase 3 CRL.

madsdawud

Your “interesting” comment is irrelevant. Hope whatever makes you think approval is more likely than CRL is more material.

sunnythehamster

Posting for job roles doesn't mean anything here. Companies can post as many job adverts as they want without actually hiring, to get some good candidates in mind as they wait an FDA decision. That way if they get a CRL it's not financial loss to have posted the roles, and if they get the approval they can hit the ground running on the commercial side

ClearEconomics5062

I entered with a modest position a few weeks ago with the upcoming decision. From what I understand the previous CRL wasn’t due to the science or clinical data - but moreso manufacturing data, so more a paperwork thing than indicative of the drug not working. In fact, the whole submission and resubmission process seems to be on the FDAs end - changing reviewers midway through etc I’m not big on biostocks but the recent drop in price and imminent positive ( 🤞 ) news should see this go on a solid run real soon

Still_Hippo928

I personally did a very extensive research on this stock before I decided to go all in after concluding that approval definitely looks way more likely than a CRL. And interestingly, about 13 hours ago they posted a senior commercial role on LinkedIn, why would a pre-revenue company be ramping up commercial leadership right now?

Athena_Gold

I've seen stock prices plunge even after receiving FDA approval. So I agree, it really comes down to your risk tolerance. This upcoming decision is interesting because it's CMC related rather than efficacy. RCKT initially received a CRL solely due to CMC deficiencies.

Scquwer

They don’t announce on the weekend so we can expect Friday after hours. It’s possible they announce early up to a few days and a CMC scenario for a CRL has the highest possibility of having an early announcement that said it’s still a low chance and I would expect it after hours Friday.

ddegeneracy

This time was the nail in the coffin. A CRL 3 times??? Good luck if you buy this garbage this will never see $5 again

BobbyTropics

Yeah it’s another CRL I’m 5k shares short right now

Avish_Golakiya

Deramiocel (CAP-1002) for DMD cardiomyopathy is a CRL-fix, not a redo situation: HOPE-3 had real signals (PUL + LVEF), and FDA’s Jan update suggests they mainly want the full CSR/analyses, so \~62% PoA feels like a fair, cautiously-bullish midpoint.

Scquwer

I think we’re mostly aligned on the FDA probability side: procedural/CMC CRL, strong efficacy and safety, which is why I personally lean 70–80% for a clean approval. Your 65% conservative take makes sense too. Where I’d expand on the longer-term picture is that it’s not just about this one therapy. Approval here is a signal that Rocket can execute: get a complex gene therapy through the FDA, demonstrate robust science, and address operational hurdles. That optics effect matters for the next programs in their pipeline; it validates the company’s approach and opens doors for subsequent rare disease assets. Even if this particular patient population is small, the market will likely view RCKT differently as a company that gets things done, which can support future value creation beyond the one therapy. So while short-term trading post-approval is always uncertain given the tiny population, the broader story is more about credibility, pipeline momentum, and the proof that they can deliver on science and regulatory execution.

Scquwer

March 28 is the FDA’s action (PDUFA) deadline. In most cases, the decision comes on that date or very close to it. Occasionally you’ll see approvals come a few days early, and less commonly you’ll see a delay if the FDA needs more time. In RCKT’s case (Rocket Pharmaceuticals), the prior CRL was tied to limited CMC/manufacturing issues rather than efficacy or safety concerns. Since the clinical endpoints were met and this resubmission is focused on addressing those manufacturing items, that arguably reduces scientific uncertainty. That said, manufacturing reviews are still procedural and inspection-driven, so there isn’t a strong structural reason to assume it comes early. Statistically speaking, I’d expect the decision on or around March 28 unless we hear otherwise.

creemeeseason

The ability of AI to develop new therapies has been rapidly gaining traction the last few months. It's mind boggling how much development is going on right now. Peter Mantas posts on X and Substack about it if you want a good starting point. As far as CRL... they'll probably benefit some. MEDP is a similar company that tends to be much better run than CRL, and the stocks have reflected that. Worth a look into. There's a lot of pick and shovel plays too. I own TWST who make synthetic DNA for testing and development. There's pharma supply names too, RGEN comes to mind. Something like TRNS does a lot with lab calibration too.

Orange_Codex

Usually sell, with a few exceptions (e.g. it's just a CRL or offtake cancellation for an otherwise-solid company).

Orange_Codex

The best way to make money in penny stocks (without specialist knowledge) seems to be shameless bottom-feeding - assuming you check for delisting and insolvency first. A biotech dumped 40% after a CRL? Buy it. A stock reverse-split its float down to six figures? Buy it. An exploratory miner has been a *long* time without news? Buy it. A distressed but recognised brand is undergoing a high-demand thematic shift (and isn't Black Rifle Coffee)? Buy it. Bad geopolitical news? Buy it. Sector stopped being in the headlines? Buy it. Conversely, chasing headlines and rallies (except for five-minute 10-20% runs) is the worst thing you can do. You'll win as often as you lose if you're lucky. If you aren't lucky, or are generally too busy to keep an eye on the market, you'll get shafted time and time again.

Own-Employee9468

AQST up 20% off CRL announcement

Own-Employee9468

AQST announced receipt of a CRL for Anaphylm, FDA cited human factors (ease of opening packet + placement of film within packet) and have asked for supportive PK data to show that any adjustments to this won't impact efficacy.

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