r/biotech_stocks • • 4h ago

IVA and SLS best biotech bets for 2026. 🎯

14 Upvotes

Inventiva and Sellas Life Science


r/biotech_stocks • • 8h ago

IVVD - A prime oppurtunity to go big or go broke?

12 Upvotes

Hi all, I used AI to draft some of this, as well as my research. I think IVVD is genuinely a 2-3x stock depending on how the trials go and FDA reception. If it fails, I think this company is done for.

  • Invivyd (IVVD) makes ready-made antibody shots that prevent COVID, basically an alternative to vaccines for people who dont respond to them or dont want mRNA.
  • Their next-gen shot VYD2311 has a 2,400 person placebo controlled Phase 3 (DECLARATION) with topline due in October 2026.
  • At $0.61 (~$180m mkt cap) the market is implying roughly 18% chance of success. My estimate is ~40%.
  • Probability weighted value ~$1.21/share. BUT the most likely single outcome is a big loss if the trial fails. Treat this like an option not an investment.

What the company does

Product What it is Status
Pemgarda Antibody infusion to prevent COVID in immunocompromised people Selling ~$14m/quarter (+21% y/y) under emergency authorization. FDA gave 12 months' notice that the EUA ends around June 2027
VYD2311 Next-gen antibody, simple intramuscular shot (like a vaccine), designed for current variants Two Phase 3s. Plan is to file under FDA Accelerated Approval

The pitch: a covid shot for people whose immune systems dont respond to vaccines (transplant, cancer, autoimmune patients). Potentially also anyone who’d rather not take an mRNA vaccine, which is a bigger group given where HHS is on mRNA right now.

The catalysts

Trial Size Question Result
LIBERTY (Ph3) ~210 Safety/tolerability vs Pfizer’s mRNA vaccine, does it interfere with the vaccine? Positive (29 Sep 2026). Fewer side effects and injection site reactions than Comirnaty, no interference
DECLARATION (Ph3) ~2,400 Does VYD2311 prevent symptomatic COVID vs placebo over 3 months? ⏳ Due October 2026 (slipped from Q3)

The stock actually dropped ~12% on the positive LIBERTY news. Market focused on the DECLARATION delay and cash burn instead.

Bull case

  1. Mechanism has worked before. Preventive covid antibodies cut symptomatic infections ~75-77% in big placebo controlled trials when they were matched to the circulating variants (AZ’s Evusheld, Invivyd’s own adintrevimab). VYD2311 uses the same antibody backbone as Invivyds existing products.
  2. Well designed trial. Randomized, triple blind, placebo controlled. They upsized it by ~500 people through a pre-planned blinded re-estimation to protect stat power.
  3. Real revenue already. Pemgarda proves theres a paying market.
  4. Policy tailwind. HHS has narrowed mRNA vaccine recommendations. An antibody shot thats better tolerated than mRNA has a pretty clear positioning story.
  5. Priced near cash. ~$180m mkt cap vs ~$118m est. cash. You’re paying roughly $60m for the drug.
  6. Option value. Long COVID Phase 2 (FLINTLOCK) started 14 Oct.

Bear case (pls actually read this part)

  1. Binary. If DECLARATION misses I think this goes to ~$0.15-0.20.
  2. The delay is unexplained. Could be event accrual (fewer covid cases = less stat power) or could be nothing. The upsizing suggests case counts were uncertain.
  3. Variant risk. Evusheld and sotrovimab both got pulled when variants escaped them. VYD2311 targets a more conserved site but the risk isnt zero.
  4. Regulatory path is untested. No covid antibody has been fully approved for broad prevention, and FDA is already ending Pemgarda’s EUA.
  5. Cash/dilution. H1 burn was ~$85m and theres a going concern warning. A raise is very likely even if the trial succeeds.
  6. Sub-$1 share price. Nasdaq compliance risk, possible reverse split.
  7. Payers. An antibody costs way more per dose than a vaccine, insurers might push back.

Valuation (my numbers, rough)

Outcome My probability Value/share vs $0.61
Trial fails or FDA says no 60% ~$0.16 -74%
Approved, niche (immunocompromised + vaccine hesitant), ~$250m sales by 2030 28% ~$0.95 +56%
Approved, broad vaccine alternative, ~$1bn sales by 2030 12% ~$7.04 +1,060%
Probability weighted ~$1.21 +99%

Method: 2030 sales x margin x P/E, discounted 4 yrs at 15%, plus cash, minus ~$200m future funding needs, with shares diluted to ~450m. At $0.61 the market is only implying ~18% odds of success.

How I get to 40%: ~60-65% the trial is clearly positive x ~65% FDA accepts the accelerated route.


r/biotech_stocks • • 12h ago

IBRX Stock Rallies After FDA Clears Broader Anktiva Use In Bladder Cancer Months Ahead Of Deadline

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7 Upvotes

🚀🚀🚀🚀‼️‼️‼️🔥🔥🔥🔥 ARE WE READY PEOPLE!!!!!!????


r/biotech_stocks • • 9h ago

Preprint shows an approved migraine drug from Pfizer blocks gastroesophageal junction tumour initiation in mice by interrupting a microbial succinate circuit

4 Upvotes

A new preprint reports that bile acid remodelling enriches the oral bacterium Prevotella melaninogenica at the gastroesophageal junction. Bacterial succinate activates tuft cells and vagal sensory neurons via the SUCNR1 receptor, which releases a prostaglandin that sensitises the neurons, and neuronal CGRP then expands epithelial progenitors through RAMP1 in a self-reinforcing loop that drives dysplasia. Administering the approved CGRP antagonist rimegepant suppressed tumour development in the mice. Prior work had tied CGRP-RAMP1 signalling to the growth of already-established colorectal and gastric tumours; this preprint places the circuit at the initiation stage and shows an approved oral drug can interrupt it.

Source:
https://doi.org/10.64898/2026.10.13.759004

Here's what I think this implies:

Pfizer (PFE) owns and markets rimegepant as Nurtec ODT and Vydura. If the circuit holds in humans, the drug becomes a candidate for pharmacological chemoprevention in high-risk Barrett's oesophagus patients, who currently have only endoscopic surveillance and ablation. Because the medicine is already approved with established safety data, the next step is a trial design rather than a full discovery programme.

AbbVie (ABBV) markets ubrogepant and atogepant, two other oral CGRP receptor antagonists in the same gepant class. A class-level chemoprevention indication would extend exposure to those products as well, though the preprint tested only rimegepant.

Catalyst: The earliest observable confirmation would be an independent group reporting the Prevotella-succinate-SUCNR1 tuft-cell circuit in a separate model or in human junction tissue, or registration on ClinicalTrials.gov of a trial of rimegepant or another gepant in Barrett's oesophagus or gastroesophageal junction dysplasia. Both sit in the medium term, roughly 6 to 24 months.

Invalidation: If the rimegepant effect fails to reproduce in an independent gastroesophageal junction tumorigenesis model, or if human Barrett's and junction dysplasia tissue lacks the Prevotella melaninogenica enrichment and SUCNR1-positive tuft-cell activation the circuit depends on.


r/biotech_stocks • • 3h ago

Erda infitinib

1 Upvotes

Can someone give me a source where i can get Erda infitinib to grow


r/biotech_stocks • • 10h ago

Liquidia and United Therapeutics Settle Inhaled Treprostinil Fight

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2 Upvotes

r/biotech_stocks • • 1d ago

SLS 🚀

65 Upvotes

The 80th-event announcement could drop any day. Two AML programs, a funded runway, and a stacked Q4 is why I'm holding through all the noise. I know it's a binary phase 3 and I size for that, but the asymmetry here is why I'm long!! Currently hold just under 30k shares and I’ve never been more bullish.


r/biotech_stocks • • 8h ago

Updates for Getting Payment on the iRhythm Technologies $45M Settlement

1 Upvotes

Hey guys, iRhythm agreed to a $45 million settlement over claims involving its Zio AT device, including data accuracy and its use in high-risk patients. Late claims are being considered, subject to approval.

The case alleged that iRhythm misled investors about Zio AT’s capabilities and growth prospects. After regulatory concerns became public, $IRTC fell 6.09%, losing more than $227 million in market value.

The claim deadline passed but late claims may still be considered for compensation.

If you invested in $IRTC during the class period, you can check the details here

Anyway, has anyone here sold iRhythm Technologies stock at that time? How much were your losses, if so?


r/biotech_stocks • • 11h ago

RXRX 10/15 recap: $200M raise at $3.25 + Sanofi milestone + REC-4881 update. Dilution vs. runway

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1 Upvotes

r/biotech_stocks • • 11h ago

NRXP

1 Upvotes

https://ir.nrxpharma.com/news-releases/news-release-details/nrx-pharmaceuticals-announces-receipt-fda-labeling-review-letter

Looks like goods news out for current FDA review of NRXP; down to the final label. Get it done, NRXP! Hopefully , approval by or before 11/10/26 GDUFA.!


r/biotech_stocks • • 16h ago

A positive post on Novo highlights

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2 Upvotes

r/biotech_stocks • • 12h ago

Protara Therapeutics (NASDAQ: TARA) Completes 24-Pt enrollment of the open-label dose confirmation phase of the THRIVE-3 clinical trial; interim results expected in 4Q 2026

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1 Upvotes
  • THRIVE-3 clinical trial is evaluating IV Choline Chloride in patients with intestinal failure who are dependent on parenteral support (PS).
  • The Phase 2b portion of the study is an open-label dose confirmation trial of 24 patients, designed to evaluate the safety and pharmacokinetics of IV Choline Chloride across multiple doses and to select dose(s) for continued evaluation.
  • Phase 2b open label cohort interim results are on track for readout in 4Q 2026.

r/biotech_stocks • • 12h ago

OTLK: 18 NEW REGIONAL KEY ACCOUNT MANAGERS — THE U.S. LAUNCH BUILD-OUT IS GETTING REAL

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1 Upvotes

r/biotech_stocks • • 1d ago

IBRX receives Anktiva approval for non-muscle invasive bladder cancer - the approval that was slated for January 6th

11 Upvotes

Blackrock has been loading up for a few weeks, with the stock up 25% in one month. Also 124mil shares shorted (30% of float), but almost 0 cost to borrow.


r/biotech_stocks • • 1d ago

IBRX Stock Rallies After FDA Clears Broader Anktiva Use In Bladder Cancer Months Ahead Of Deadline

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8 Upvotes

r/biotech_stocks • • 1d ago

Approval Today!!!

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7 Upvotes

r/biotech_stocks • • 20h ago

IBRX Stock Rallies After FDA Clears Broader Anktiva Use In Bladder Cancer Months Ahead Of Deadline

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1 Upvotes

🚀🚀🚀🚀‼️‼️‼️🔥🔥🔥🔥 ARE WE READY PEOPLE!!!!!!????


r/biotech_stocks • • 1d ago

MediciNova's Ibudilast: Why are analysts so bullish on a drug that doesn't even work?

4 Upvotes

I've been digging into MediciNova (MNOV), which is expected to release Phase 2b/3 data for ibudilast (MN-166) by the end of 2026. The problem is... I'm struggling to find any evidence that this drug actually works!

The Phase 2 ALS trial failed its clinical endpoint (ALSFRS-R mean change from baseline), instead showing that patients who took the drug became sicker than placebo. This trend also occurred with secondary endpoints (SVD and MMT mean change from baseline).

Instead, the company seems to emphasize post-hoc subgroups, most of which weren't even statistically significant! Digging deeper raises even more questions. MediciNova originally licensed for MS and was in clinical trials for 7 other diseases before ALS! Seems like they're throwing it at everything to see what sticks.

Meanwhile, sell-side analysts are publishing bullish price targets ahead of the readout. I understand that small trials can miss real treatment effects, but I'm having trouble understanding what clinical evidence supports the level of optimism surrounding this program.

https://medicinova.com/


r/biotech_stocks • • 1d ago

IBRX approval!

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3 Upvotes

r/biotech_stocks • • 1d ago

IBRX Stock Rallies After FDA Clears Broader Anktiva Use In Bladder Cancer Months Ahead Of Deadline

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2 Upvotes

r/biotech_stocks • • 1d ago

Is it a yes??

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2 Upvotes

r/biotech_stocks • • 1d ago

Yet another free biotech screener

6 Upvotes

I've been working (with claude) on caphelix.io, basically a biotech screener with past and upcoming events spread out on a timeline.

It also has event and company filtering, insider tracking, drug description / TAM / competitors, financials (runway, burn, marketcap, price data, etc. ) and a bunch of other stuff

I wanted it to be more data-oriented (it has mcp/api integration, but that's with a signup)

It's still a work in progress and I'm actively working on data accuracy, but let me know what you think


r/biotech_stocks • • 1d ago

Orthogonal chemokine-receptor pairs from a new preprint aim to program where engineered T cells go inside solid tissue

2 Upvotes

A preprint dated 14 October 2026 used structure-guided design to build chemokine-receptor pairs that talk to each other with low crosstalk to the body's own chemokine system. T cells carrying the matching receptor moved into tissues that produced the orthogonal chemokine, both in culture and in mice. Cells set up to both release and sense the same orthogonal chemokine formed swarms, with early arrivals pulling more cells in along a gradient the cells themselves created.

Source:
https://doi.org/10.64898/2026.10.12.758398

Here's what I think this implies:

Immatics N.V. (IMTX) is developing engineered TCR T-cell therapies for solid tumors. Getting those cells into the tumor is the central clinical problem the company faces. A low-crosstalk system that lets the cells follow a programmable gradient, and then recruit more of themselves once they arrive, would give programs like that a way to control infiltration instead of leaving it to the host tissue.

Iovance Biotherapeutics, Inc. (IOVA) commercializes tumor-infiltrating-lymphocyte therapy. That product is built on the idea that the cells you infuse are already living inside the tumor. If engineered T cells of any kind can be directed into solid tissue by an orthogonal gradient the developer controls, the edge that comes from starting with tumor-resident cells gets smaller.

The first clear confirmation would be an independent group showing the same directed trafficking in a second model or in human T cells, or a developer announcing that it licensed the designs, somewhere in the next 6 to 24 months.

It would not matter if later work finds the receptor still answers to ordinary chemokines at normal levels inside human T cells, or if no practical method can put the orthogonal chemokine gradient inside a tumor that was not engineered to make it.


r/biotech_stocks • • 1d ago

IBRX receives Anktiva approval for non-muscle invasive bladder cancer - the approval that was slated for January 6th

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1 Upvotes

r/biotech_stocks • • 1d ago

whoa, under cover approval/NMIBC HIGH GRADE today.

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0 Upvotes