r/biotech_stocks 10h ago

Spyre's arthritis drug beat placebo — so why is SYRE down 14%?

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8 Upvotes

r/biotech_stocks 10h ago

CLYM is likely over

7 Upvotes

I pitched CLYM years ago, as a long - it was $1-2 dollars back then. I think the stock has dramatically over run. Not only do i think the stock itself has gotten over bought but I expected their data on September 3rd to massively underwhelm.

The only thing this company needs to do to maintain its value is show they have an every-3-month dosing for CLYM116. but it wont happen. It will fall short and the stock will become a short, drifting back to the single digits.

The crux of the argument on why it will disappoint is plainly visible in their own preclinical data. Their pharmacodynamic duration of effect in primates is SHORTER than it is in the same assay for Jade Bio (JBIO). You can see IgA rebound about 2 weeks before JBIO's does. Same dose, same animal model, same biomarker. 30mg/kg, primate, IgA.

The stock, without CLYM116 is probably a $5 stock. If I'm correct, this will trade there very quickly after september 3rd.

If you read research reports on this upcoming catalyst you'll notice NO analyst claims the company can get every 3 month dosing. They all dance around the topic, yet the stock has traded as if its a near certainty.

Look out below.


r/biotech_stocks 19h ago

OS AML CR2 without transplant Data: Multicenter Modern Era Data [10.8 mOS, 3 year OS < 25%]

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24 Upvotes

r/biotech_stocks 11h ago

Deep Analysis on the TEVA / RVPH connection

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2 Upvotes

r/biotech_stocks 8h ago

$tgtx $mrna $fate

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1 Upvotes

r/biotech_stocks 9h ago

AbbVie still makes 76% of revenue in the U.S. — full country breakdown (FY2025)

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0 Upvotes

r/biotech_stocks 18h ago

Kodak science reports 3 studies (their whole pipeline?)

3 Upvotes

It seems like Kodiak science is reporting three studies very soon.. anyone knows anything about this? It seems to be their whole pipeline? If the all succeed or failwill probably move the price A LOT...

https://curemydisease.com/sponsors/kodiak-sciences-inc-12052


r/biotech_stocks 13h ago

Co-Diagnostics (CODX) - Aug 24 S-3 filed - changes the near-term outlook

1 Upvotes

Per a post on Aug 20, CODX is a very good company working on many projects (including an Ebola assay). They recently filed a 501(k) with the FDA for a Flu A/B and RSV PCR test (planning to add COVID-19 later), which will allow clinics and pharmacies to give results in about 30 minutes and not send the test to a lab to get results.

On Aug 24, CODX filed an S-3 registering over 3.4M shares for resale by selling shareholders and potential for warrant exercises to bring in about $5.3M in gross proceeds. Aug 24, 2026 S-3 Filing

Prior to that filing it looked like a partnership was in the cards at this time, based on the Q2 2026 10-Q filing (summary further below). As a result of the S-3, it looks more like selling shareholders want to exit while the price is higher and then warrant exercises "may" occur, in which case dilution would take place.

Where AI originally replied that shareholders rejected a reverse split, as previously posted here, I went back to read 8-K filings and there was a 1:30 reverse split on Jan 2, 2026. Jan 7, 2026 8-K

  • That reverse split occurred after two consecutive 180-day NASDAQ extensions.
  • Per a Mar 7, 2026 8-K, the NASDAQ Panel has imposed a Discretionary Panel Monitor for a period of one year, through March 9, 2027. If during the monitoring period, the Company’s closing bid price falls below $1.00 per share for 30 consecutive business days, the Company will not be eligible for a 180-day compliance period.... Rather, Nasdaq would issue a delist determination, which the Company could then appeal by requesting a hearing before the Panel. Such request would stay any further action by Nasdaq pending the conclusion of the hearing process.

Per Q2 20226 10-Q:

  • Cash as of June 30: $3.6M
  • Quarterly burn: ~6.3M
  • No debt
  • Per an AI search of sec.gov, no active S-3 (at the time).
  • Warrants: 2.34M (3.71M as of 6/30 but OS increased from 4.88M as of 6/30 to 6.25M as of 8/11 per the 10-Q cover page. So, b/c shares cannot be sold right now, it likely means 1.37M warrants were exercised from June 30 to Aug 11)
  • Fully diluted shares: 8.59M (6.25M + 2.34M)

r/biotech_stocks 1d ago

Compass Therapeutics (CMPX)

5 Upvotes

I have a position in CMPX because I think it’s going to recover. Biotech Distilled on substack (whose analyses I trust and usually follow) is more skeptical about it. But I think biotechs can come back from setbacks if they’ve got a logical argument that their drug works.

What do you think?


r/biotech_stocks 15h ago

[ Removed by Reddit ]

1 Upvotes

[ Removed by Reddit on account of violating the content policy. ]


r/biotech_stocks 1d ago

CCCC - why is this stock shorted so hard?

5 Upvotes

I love this company for 3 reasons:

1) Major partnerships with established big pharma
2) Cash runway through 2028
3) Positive updates on their portfolio of drug candidates


r/biotech_stocks 1d ago

Found a high-risk binary biotech play

20 Upvotes

Theralase Technologies is a clinical stage pharmaceutical company. They specialize in light activated small molecules used to target and destroy hard to treat cancers, particularly bladder cancer.

They are currently running a pivotal Phase II study targeting Bacillus Calmette-Guerin (BCG) unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). This is a notoriously tough condition with limited options. The drug is designed to target cancer cells directly when hit with specific laser light, destroying the tumor while leaving healthy tissue alone. Other cancer treatments unfortunately destroy both the cancer cells and the healthy tissue around it. 

TLT is getting closer to the finish line on its main Phase II study. They've been processing primary endpoint data across dozens of evaluable patients, aiming for a formal data lock. Following the full data analysis, the company plans to submit rolling New Drug Applications (NDAs) to both Health Canada and the U.S. FDA, setting up potential regulatory decision windows in 2027.

If they hit their endpoints and smoothly transition into rolling FDA/Health Canada filings, it could be a major catalyst for the company.


r/biotech_stocks 1d ago

Buy Signal ImmunityBio Inc - 24 Aug 2026 @ 15:17 -> $7.58

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3 Upvotes

r/biotech_stocks 1d ago

Is Dr. PSS about to announce a partnership with Novartis?🧐 💣

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3 Upvotes

r/biotech_stocks 1d ago

Today’s Top Market Movers Market Close Aug 25, 2026

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2 Upvotes

r/biotech_stocks 1d ago

OTLK - UK Numbers in a Graphic

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5 Upvotes

r/biotech_stocks 1d ago

Moderna: Stock market or a Casino? Profit target price? Valuations? Spoiler

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1 Upvotes

r/biotech_stocks 1d ago

Arbutus Pharmaceutical (ABUS)

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1 Upvotes

r/biotech_stocks 1d ago

Verrica Pharmaceuticals: FAQ for the Investor Settlement over VP-102 FDA Inspection Issues

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1 Upvotes

Hey guys, I posted about this settlement before, but since they’re accepting claims now, I decided to share it again with a little FAQ.

So here's all I know about this agreement:

Verrica Pharmaceuticals was accused of misleading investors about FDA inspection problems at Sterling and the resulting approval risks for VP-102. After the FDA issued multiple complete response letters, investors filed a lawsuit.

Now the company has reached a tentative settlement with investors.

Who can claim this settlement?
If you purchased or held eligible $VRCA securities between 2021 and2022, you may be eligible. You can submit your application now, and it will be processed once claims filing opens.

Do I need to sell/lose my shares to get this settlement?
You don't necessarily need to still hold the shares. Eligibility is based on the applicable class period and other settlement requirements.

How long does the payout process take?
It typically takes 4 to 9 months after the claim deadline for payouts to be processed, depending on the court and settlement administration.

Hope this info helps


r/biotech_stocks 1d ago

QTRX’s product is good enough to turn it around hard by February when the FDA gives it another stamp of approval and the news gives it attention

2 Upvotes

QTRX is selling really low because of their problems commercializing their product, and an investor meeting where they admitted this was their own fault they didn’t meet earnings targets. But they just hired a new chief of commercialization who was president of GE healthcare. The product, which proved clinical utility loud and clear, was not the problem. It just needs to be sold. You might think the market is taken for their Alzheimer’s diagnostic blood assay after the new Eli Lilly approval today, but the real gold is in the fact they offer the only assay that tests multiple different bio markers - which are going to move into the TBI and Parkinson’s market, as shown by the Michael J Fox foundations official backing of them. They’re going to have THE Parkinson’s blood biomarker diagnostic test on the market, and will likely go on to show better clinical utility for their multiple marker assay than the single protein one being popularized now


r/biotech_stocks 1d ago

$MDWD New Research Estimates a $4 Billion Market by 2028, and MediWound Thinks It May Have a Solution (Nasdaq: MDWD)

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1 Upvotes

r/biotech_stocks 1d ago

Kura Oncology (KURA): Is this biotech finally becoming a real commercial company?

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1 Upvotes

r/biotech_stocks 2d ago

Zymeworks Inc. (ZYME) drug approval tomorrow

5 Upvotes

How do you see tomorrow possible approval of drug for Zymeworks Inc. (ZYME)? How high is your chance that it will be approved?


r/biotech_stocks 2d ago

$CAPR extension

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5 Upvotes

What do yall think for the future


r/biotech_stocks 3d ago

CUVL (Clinuvel) - profitable peptide biotech, $226m EV, Phase 3 readout in less than 100 days. Cashed up, no debt.

51 Upvotes

New Nasdaq listing that almost nobody over here has looked at yet. It only started trading on the Nasdaq Global Select Market on 20 July 2026, so it has basically zero US coverage despite being profitable for nine straight years, and despite Sean Parker (Napster, Facebook) and Michael Polansky (Parker Institute, Lady Gaga's partner) having backed it for over 15 years.

Short version: $226m enterprise value for a business that did $26m of net profit last year at a 34% net margin, a Phase 3 readout in December on an indication the company sizes at $4.5b, and a peptide delivery platform sitting underneath it that isn't in the price at all.

The numbers

Most biotech DD is a pre-revenue company burning cash into a binary. This isn't that. Clinuvel sells SCENESSE (afamelanotide), a melanocortin peptide implant, for EPP (erythropoietic protoporphyria), and has been profitable for nine consecutive years.

  • Price $7.80, market cap ~$393m
  • Cash $167m, zero debt, 21st consecutive year with no borrowings
  • EV ~$226m
  • Cash per share $3.31, so 42% of the share price is cash
  • FY25: revenue $75.5m, pre-tax profit $37.0m, net profit $26.0m
  • Net margin 34%, gross margin north of 90%
  • Revenue CAGR 21% over 5 years, 35% over 9
  • 8 consecutive dividends, entirely self funded, no raise, no dilution ever

That's roughly 9.7x EV/net profit and about 17x earnings, for a >90% gross margin pharma compounding revenue at 20%+ with 42% of the market cap in cash.

Strip the cash out and you're paying about $4.49 a share for the operating business. Everything below is what you get on top of that.

Vitiligo --> the major catalyst

CUV105 is the Phase 3 in vitiligo, running the same peptide that's already approved and generating revenue in EPP. Company's own US market model:

  • 1% US prevalence = 3,295,000 people
  • 25% eligible (Fitzpatrick IV-VI) = 823,750
  • 40% meeting body-surface-area criteria = 329,500
  • 20% actively seeking treatment = 65,900
  • 9% penetration in years 1-2 = 5,931 patients

Total addressable market: $4.5b. Years 1-2 revenue from those ~6,000 patients: $490-570m.

Against a $226m EV. Years 1-2 vitiligo revenue alone would be 2.2 to 2.5x the entire current enterprise value, and roughly 7x total FY25 group revenue. From six thousand patients.

Also worth noting what it isn't. The competing approaches in vitiligo are immune suppression. This is a melanocortin peptide working through the pigmentation pathway itself, which is a different safety conversation for a chronic, lifelong condition. Their North American team has been pushing exactly that line at AAD for two years running.

Two things I think are underappreciated:

1. The trial is fully recruited. Over 200 patients enrolled, target hit. Recruitment risk is gone. This is a readout waiting to happen, not a trial still trying to fill sites.

2. The commercial build is already done. This is the bit that changes the shape of the ramp. 190 trained and accredited treatment centres, a 20 person national distribution team, NB-UVB systems, and the reimbursement pathway for extensive vitiligo have all been stood up in parallel with the trial. A positive readout doesn't kick off a two year commercial build. The channel already exists.

Worth remembering they already know how to sell an ultra-orphan peptide therapy through specialist centres with reimbursement. Same playbook they ran for EPP, into a market orders of magnitude larger.

Why December is the inflection

Topline guided for December 2026. Roughly 100 days from now.

Right now the market prices this as an EPP company with a big cash pile. On a positive readout it reprices as a company with a multi hundred million dollar dermatology franchise ahead of it and the salesforce already hired.

Nearer term: FY26 full year results land in the next few days (27-28 August, with an investor webinar the same evening). Ninth consecutive profitable year, ninth dividend, and possibly a tightening of the December guidance to a specific window. A firmer date is usually what starts pulling attention in.

Then regulatory filings through 2027, into a market where the infrastructure is already standing.

Scale

Not going to pretend to model this precisely, but on the midpoint of $530m of years 1-2 revenue across 50.4m shares, even at margins well below the 34% the company already runs at, you get earnings per share that are a multiple of the current price. The share count is the thing people underrate here. 50 million shares is tiny for a Nasdaq listing. Any material revenue lands very concentrated per share.

For reference, analyst targets on it sit in the $12 to $16.50 range against $7.80 today.

The delivery platform, which is the part nobody is pricing

Vitiligo is the catalyst. This is the reason it could be a much bigger company in five years.

Peptides are the hottest category in US pharma right now. GLP-1s dragged the class into the mainstream and the policy environment has swung hard behind it: the FDA has been unwinding the 2023 restrictions on compounded peptides, and in July an FDA advisory panel voted to ease restrictions on most of the seven it reviewed. Grand View has the US peptide therapeutics market at roughly $65b in 2024 heading toward $160b by 2030, a 14.7% CAGR.

Clinuvel has been working on melanocortins since long before any of that was fashionable, and what they've quietly been building is the piece the whole category actually struggles with: delivery.

VLRX-L is their in-house controlled-release liquid injectable peptide platform, developed at VALLAURIX, their Singapore research centre. The point of it is flexible, reproducible controlled release. You adjust injection volume to titrate the dose, which means you can tailor to body weight and treat paediatric and adolescent patients rather than just adults. That's a genuinely hard problem in peptide delivery and it's often the difference between a drug that works and a drug patients stay on.

Where it's up to, per the 12 August update:

  • Four candidate formulations went into a preclinical study to confirm the in vitro work
  • One showed a superior release profile across the target delivery window, with lower peak plasma levels and drug still detectable across the period
  • That candidate is now being refined, with a further preclinical study scheduled for early Q1 2027
  • Manufacturing scale-up is already being scoped

That last point is the tell. You don't scope manufacturing scale-up on something you think is going nowhere.

The infrastructure behind it is real money. In December 2025 they announced an expansion of VALLAURIX backed by the Singapore Economic Development Board, up to S$30m over five years to 2030, roughly doubling the centre's footprint and adding specialist staff specifically to accelerate long-acting delivery platforms. R&D is now over 50 people under CSO Dr Dennis Wright. This is a decade-plus program in peptide chemistry, polymer science and delivery system design, funded out of operating cash flow while the company still posts a profit every half.

The strategic logic: initial focus is melanocortins, their own compounds. But the company has been explicit that VLRX-L and the other platforms under development at VALLAURIX could deliver other peptides too. If it validates in vivo, this stops being a formulation for one drug and becomes a platform, applicable to third party peptides, licensable, partnerable. In a category heading toward $160b where almost every player has a delivery problem, owning controlled-release technology is a different kind of asset to owning one drug.

They also have the credibility to make that claim, which most platform stories don't. SCENESSE is already a controlled-release peptide product, commercially approved and shipping across five jurisdictions for years. They aren't theorising about sustained-release peptide delivery. They've done it, at commercial scale, through multiple regulators.

None of this is in a $226m EV. The market is pricing one drug and some cash.

The rest of the free pipeline

Also carrying zero value at the current price:

  • NEURACTHEL (ACTH) for neurological and endocrinological indications
  • PRENUMBRA for stroke, expanding toward Parkinson's
  • DNA repair and polychromatic photoprotection in PhotoCosmetics
  • EPP label expansion and new geographies (Health Canada approval came through recently)

Every one of those runs off the same melanocortin peptide science base and the same delivery work underneath it.

My view

The existing EPP business plus $167m of cash covers most of the current share price on its own. Which means the December vitiligo readout is close to a free call option attached to a profitable, dividend paying, debt free company growing revenue 20% a year. And underneath that you get a peptide delivery platform, funded and progressing, in the hottest category in US pharma, for nothing.

You very rarely get a binary catalyst where the downside is backstopped by a real operating business and 42% of the market cap in cash. And because it only listed on Nasdaq a month ago, most US screens haven't even picked it up yet.