Inventiva and Sellas Life Science

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

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

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)

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.

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

Hey everyone,

Dev behind CatalystAlert.io here, back with the monthly FDA rundown. Before the new list, I owe you a scorecard on the last one.

How my August list held up

In August I posted 8 upcoming FDA decisions. Here is what happened to each one:

* SRRK (Scholar Rock), Sep 30: approved on Sep 11 as Isembyld (apitegromab) for SMA, 19 days before the goal date.

* NUVB (Nuvation Bio), Oct 1: wrong. That "prostate cancer program" PDUFA did not exist. Nuvation's real FDA event was a label update for Ibtrozi (taletrectinib), approved in mid September, about four months before its Jan 4, 2027 goal date.

* AGIO (Agios), Nov 1: still on. Mitapivat in sickle cell disease, it's in the calendar below.

* TLX (Telix), Nov 15: not supported. In its August filing Telix said the TLX250-CDx resubmission was still being prepared, and I can't find an accepted resubmission or a new goal date. Removed.

* VRTX (Vertex), Nov 30: right date, wrong indication. Povetacicept is filed in IgA nephropathy, not primary membranous nephropathy.

* SMMT (Summit), Nov 30: wrong. Ivonescimab is filed in EGFR-mutated lung cancer, not colorectal, and the date is Nov 14.

* MRK (Merck), zanzalintinib, around December: wrong company and wrong indication. The filing belongs to Exelixis (EXEL), zanzalintinib with atezolizumab in colorectal cancer, and the FDA pushed it from Dec 3 to Mar 3, 2027.

* ALVO (Alvotech), vedolizumab biosimilar, around December: I flagged it as unconfirmed at the time and I still don't have a confirmed date.

So 5 of the 8 had a real error. That's on me. Those rows came from automated sources that mixed up drugs, indications and companies. This month I checked every date below by hand against the company's own press release or SEC filing, and fixed the database where it was wrong.

Already decided in October

* Oct 2, LLY: Jaypirca (pirtobrutinib) approved for previously untreated CLL/SLL.

* Oct 7, PFE: Tukysa approved as first-line maintenance in HER2-positive metastatic breast cancer.

* Oct 8, RHHBY: Tecentriq plus chemo approved in stage III dMMR colon cancer, one day before its Oct 9 date.

* Oct 9: Hovilpri (pritelivir, AiCuris and Asahi Kasei) approved for refractory herpes simplex infections in immunocompromised patients.

* Oct 14, IBRX: Anktiva label expanded to papillary-only BCG-unresponsive bladder cancer. The goal date was Jan 6, 2027, so almost three months early.

* Oct 16, RHHBY: Enspryng approved in thyroid eye disease. The goal date was Oct 15.

Three October dates were settled before the month even started. Pharming's Joenja pediatric label (PHAR) was approved Sep 11 for an Oct 24 date. Merck's Welireg plus Lenvima was approved Sep 24 for an Oct 4 date. Merck and Daiichi Sankyo withdrew the I-DXd small cell lung cancer application on Sep 25, so there was no Oct 10 decision.

The calendar, Oct 17 to Nov 30

All of these were pending as of Oct 16. Five dates fall on a weekend (Oct 17, Nov 1, Nov 14, Nov 22, Nov 28). In that case the decision usually comes on the last business day before, but it can come at any point.

* Oct 17 (Sat), VTRS: MR-141 (phentolamine eye drops) for presbyopia. sNDA, the drug is already sold as Ryzumvi for another use.

* Oct 26, GSK: bepirovirsen for chronic hepatitis B. Priority Review and Breakthrough, partnered with Ionis (IONS).

* Oct 29, Sun Pharma (not US listed): Ilumya for psoriatic arthritis. sNDA, the company says "expected by Oct 29".

* Oct 30, INO: INO-3107 for recurrent respiratory papillomatosis. BLA on the accelerated approval path, standard review. The FDA listed accelerated approval eligibility as a possible review issue.

* Nov 1 (Sun), AGIO: mitapivat for sickle cell disease. sNDA, accelerated approval, Priority Review.

* Nov 14 (Sat), CYTK: Myqorzo (aficamten) label update from MAPLE-HCM in obstructive HCM. The drug is already approved.

* Nov 14 (Sat), SMMT: ivonescimab plus chemo for EGFR-mutated lung cancer after an EGFR TKI. BLA. Overall survival was not statistically significant, and Summit sent updated survival data to the FDA.

* Nov 14 (Sat), BTAI: Igalmi for at-home use in agitation from bipolar disorder or schizophrenia. sNDA. BioXcel has been in Chapter 11 since Aug 27, Teva is the stalking horse buyer.

* Nov 22 (Sun), CAPR: deramiocel for Duchenne (upper limb function). BLA, extended from Aug 22. The advisory committee voted 9 to 3 against in July.

* Nov 22 (Sun), SVRA: Molbreevi (molgramostim) for autoimmune PAP. Priority Review, extended from Aug 22.

* Nov 25, SNY: venglustat for type 3 Gaucher disease. Priority Review.

* Nov 27, BBIO: BBP-418 for LGMD2I/R9. Priority Review.

* Nov 27, GSK: neladalkib for ALK-positive lung cancer after a prior ALK TKI. Priority Review. It came with the Nuvalent deal (closed Jul 15), and its sister drug zidesamtinib was approved Jul 22, about two months early.

* Nov 27, Zydus (not US listed): saroglitazar for PBC. Priority Review.

* Nov 28 (Sat), PYPD: D-PLEX100 to prevent surgical site infections in abdominal colorectal surgery. Priority Review.

* Nov 30, VRTX: povetacicept for IgA nephropathy. BLA, accelerated approval, Priority Review.

* Nov 30, RHHBY: giredestrant after surgery (adjuvant) in ER+/HER2- stage I to III breast cancer. Priority Review.

* Nov 30, COGT: bezuclastinib plus sunitinib for GIST after imatinib. Priority Review and Breakthrough.

November, no exact day given by the company:

* REGN cemdisiran in generalized myasthenia gravis (AChR antibody positive), Priority Review. Regeneron says "November 2026".

* RHHBY Gazyva in primary membranous nephropathy, Priority Review. Roche says "by November 2026".

Advisory committee: Oct 30, the FDA's dermatology and ophthalmology committee reviews atropine 0.01% (Sydnexis, private) to slow myopia progression in children.

Left out on purpose because there is no firm date: Pfizer Talzenna + Xtandi in prostate cancer, AstraZeneca Imfinzi + enfortumab vedotin in bladder cancer, Teva's long-acting olanzapine (TEV-'749), and Novo's Mim8, whose review was extended without a new date being published.

Decisions keep coming early

Looking back over the last few months:

* Isembyld (SRRK): 19 days early

* Welireg + Lenvima (MRK): 10 days early

* Joenja pediatric (PHAR): about 6 weeks early

* Zidesamtinib (now GSK): about 2 months early

* Anktiva papillary (IBRX): almost 3 months early

* Ibtrozi label update (NUVB): about 4 months early

Most of these are cancer drugs, where early action is more common, but not all of them. A PDUFA date is the FDA's deadline, not the day the decision has to land.

Dossiers

Every US-listed company in the calendar above has a free research dossier on the site, no account needed. For example catalystalert.io/research/CAPR or catalystalert.io/research/SMMT. Each one has the upcoming catalysts with a label on every date (confirmed, estimated or AI-detected), the pipeline, cash runway, insider and institutional activity, and a written summary of the setup. When our data on a company is thin, the dossier says so instead of claiming the company has "no catalysts".

Drop a ticker in the comments and I'll reply with the main points from its dossier. Any of the ~1,500 companies we track.

Tell me what's wrong

The August scorecard is exactly why I ask. If you see a wrong date, a drug matched to the wrong indication, a decision that already happened, a ticker mapped to the wrong company, or anything that looks off on the site, say it in the comments or DM me. I check every correction against the source and fix it in the database. Same if something on the site is confusing or missing, I'd rather hear it here.

Disclaimer: not financial advice. This is a calendar and a summary of public company announcements, nothing more. Dates move, the FDA can act early or late, and I can still get things wrong. Check the company's press release, its SEC filings or FDA.gov before relying on any of it.

November decisions, each with its source: catalystalert.io/pdufa/november-2026

Full calendar and dossiers: catalystalert.io

My eyes are glued on October 20th, that’s when I predict the data drops. Could be a wild ride, but this isn't just generic hype—the setup here is massive.

First off, the safety foundation is already solid. The Phase 3 LIBERTY readout already showed VYD2311 blowing mRNA vaccines out of the water on tolerability (56.5% AEs vs. 91.4% for mRNA, p<0.0001). The safety profile is already locked in, so we aren't walking into this blind on that front.

Second, this DECLARATION drop is the actual trigger for the stock. We aren't waiting on a multi-year readout for clinical infection events; this drop focuses on immunogenicity and serum neutralizing antibody titers. Strong titers here give management the final puzzle piece they need to trigger their planned submission under the FDA's Accelerated Approval Program.

On top of that, they upsized DECLARATION to roughly 2,400 participants to pack serious statistical power into this dataset.

If these titers come in hot against current circulating strains, it confirms VYD2311 as a dominant next-gen, IM-administered mAb platform and opens the immediate fast track to approval.

Strap in. $IVVD 👀🚀

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.

Hey everyone,

Dev behind CatalystAlert.io here, back with the monthly FDA rundown. Before the new list, I owe you a scorecard on the last one.

How my August list held up

In August I posted 8 upcoming FDA decisions. Here is what happened to each one:

* SRRK (Scholar Rock), Sep 30: approved on Sep 11 as Isembyld (apitegromab) for SMA, 19 days before the goal date.

* NUVB (Nuvation Bio), Oct 1: wrong. That "prostate cancer program" PDUFA did not exist. Nuvation's real FDA event was a label update for Ibtrozi (taletrectinib), approved in mid September, about four months before its Jan 4, 2027 goal date.

* AGIO (Agios), Nov 1: still on. Mitapivat in sickle cell disease, it's in the calendar below.

* TLX (Telix), Nov 15: not supported. In its August filing Telix said the TLX250-CDx resubmission was still being prepared, and I can't find an accepted resubmission or a new goal date. Removed.

* VRTX (Vertex), Nov 30: right date, wrong indication. Povetacicept is filed in IgA nephropathy, not primary membranous nephropathy.

* SMMT (Summit), Nov 30: wrong. Ivonescimab is filed in EGFR-mutated lung cancer, not colorectal, and the date is Nov 14.

* MRK (Merck), zanzalintinib, around December: wrong company and wrong indication. The filing belongs to Exelixis (EXEL), zanzalintinib with atezolizumab in colorectal cancer, and the FDA pushed it from Dec 3 to Mar 3, 2027.

* ALVO (Alvotech), vedolizumab biosimilar, around December: I flagged it as unconfirmed at the time and I still don't have a confirmed date.

So 5 of the 8 had a real error. That's on me. Those rows came from automated sources that mixed up drugs, indications and companies. This month I checked every date below by hand against the company's own press release or SEC filing, and fixed the database where it was wrong.

Already decided in October

* Oct 2, LLY: Jaypirca (pirtobrutinib) approved for previously untreated CLL/SLL.

* Oct 7, PFE: Tukysa approved as first-line maintenance in HER2-positive metastatic breast cancer.

* Oct 8, RHHBY: Tecentriq plus chemo approved in stage III dMMR colon cancer, one day before its Oct 9 date.

* Oct 9: Hovilpri (pritelivir, AiCuris and Asahi Kasei) approved for refractory herpes simplex infections in immunocompromised patients.

* Oct 14, IBRX: Anktiva label expanded to papillary-only BCG-unresponsive bladder cancer. The goal date was Jan 6, 2027, so almost three months early.

* Oct 16, RHHBY: Enspryng approved in thyroid eye disease. The goal date was Oct 15.

Three October dates were settled before the month even started. Pharming's Joenja pediatric label (PHAR) was approved Sep 11 for an Oct 24 date. Merck's Welireg plus Lenvima was approved Sep 24 for an Oct 4 date. Merck and Daiichi Sankyo withdrew the I-DXd small cell lung cancer application on Sep 25, so there was no Oct 10 decision.

The calendar, Oct 17 to Nov 30

All of these were pending as of Oct 16. Five dates fall on a weekend (Oct 17, Nov 1, Nov 14, Nov 22, Nov 28). In that case the decision usually comes on the last business day before, but it can come at any point.

* Oct 17 (Sat), VTRS: MR-141 (phentolamine eye drops) for presbyopia. sNDA, the drug is already sold as Ryzumvi for another use.

* Oct 26, GSK: bepirovirsen for chronic hepatitis B. Priority Review and Breakthrough, partnered with Ionis (IONS).

* Oct 29, Sun Pharma (not US listed): Ilumya for psoriatic arthritis. sNDA, the company says "expected by Oct 29".

* Oct 30, INO: INO-3107 for recurrent respiratory papillomatosis. BLA on the accelerated approval path, standard review. The FDA listed accelerated approval eligibility as a possible review issue.

* Nov 1 (Sun), AGIO: mitapivat for sickle cell disease. sNDA, accelerated approval, Priority Review.

* Nov 14 (Sat), CYTK: Myqorzo (aficamten) label update from MAPLE-HCM in obstructive HCM. The drug is already approved.

* Nov 14 (Sat), SMMT: ivonescimab plus chemo for EGFR-mutated lung cancer after an EGFR TKI. BLA. Overall survival was not statistically significant, and Summit sent updated survival data to the FDA.

* Nov 14 (Sat), BTAI: Igalmi for at-home use in agitation from bipolar disorder or schizophrenia. sNDA. BioXcel has been in Chapter 11 since Aug 27, Teva is the stalking horse buyer.

* Nov 22 (Sun), CAPR: deramiocel for Duchenne (upper limb function). BLA, extended from Aug 22. The advisory committee voted 9 to 3 against in July.

* Nov 22 (Sun), SVRA: Molbreevi (molgramostim) for autoimmune PAP. Priority Review, extended from Aug 22.

* Nov 25, SNY: venglustat for type 3 Gaucher disease. Priority Review.

* Nov 27, BBIO: BBP-418 for LGMD2I/R9. Priority Review.

* Nov 27, GSK: neladalkib for ALK-positive lung cancer after a prior ALK TKI. Priority Review. It came with the Nuvalent deal (closed Jul 15), and its sister drug zidesamtinib was approved Jul 22, about two months early.

* Nov 27, Zydus (not US listed): saroglitazar for PBC. Priority Review.

* Nov 28 (Sat), PYPD: D-PLEX100 to prevent surgical site infections in abdominal colorectal surgery. Priority Review.

* Nov 30, VRTX: povetacicept for IgA nephropathy. BLA, accelerated approval, Priority Review.

* Nov 30, RHHBY: giredestrant after surgery (adjuvant) in ER+/HER2- stage I to III breast cancer. Priority Review.

* Nov 30, COGT: bezuclastinib plus sunitinib for GIST after imatinib. Priority Review and Breakthrough.

November, no exact day given by the company:

* REGN cemdisiran in generalized myasthenia gravis (AChR antibody positive), Priority Review. Regeneron says "November 2026".

* RHHBY Gazyva in primary membranous nephropathy, Priority Review. Roche says "by November 2026".

Advisory committee: Oct 30, the FDA's dermatology and ophthalmology committee reviews atropine 0.01% (Sydnexis, private) to slow myopia progression in children.

Left out on purpose because there is no firm date: Pfizer Talzenna + Xtandi in prostate cancer, AstraZeneca Imfinzi + enfortumab vedotin in bladder cancer, Teva's long-acting olanzapine (TEV-'749), and Novo's Mim8, whose review was extended without a new date being published.

Decisions keep coming early

Looking back over the last few months:

* Isembyld (SRRK): 19 days early

* Welireg + Lenvima (MRK): 10 days early

* Joenja pediatric (PHAR): about 6 weeks early

* Zidesamtinib (now GSK): about 2 months early

* Anktiva papillary (IBRX): almost 3 months early

* Ibtrozi label update (NUVB): about 4 months early

Most of these are cancer drugs, where early action is more common, but not all of them. A PDUFA date is the FDA's deadline, not the day the decision has to land.

Dossiers

Every US-listed company in the calendar above has a free research dossier on the site, no account needed. For example catalystalert.io/research/CAPR or catalystalert.io/research/SMMT. Each one has the upcoming catalysts with a label on every date (confirmed, estimated or AI-detected), the pipeline, cash runway, insider and institutional activity, and a written summary of the setup. When our data on a company is thin, the dossier says so instead of claiming the company has "no catalysts".

Drop a ticker in the comments and I'll reply with the main points from its dossier. Any of the ~1,500 companies we track.

Tell me what's wrong

The August scorecard is exactly why I ask. If you see a wrong date, a drug matched to the wrong indication, a decision that already happened, a ticker mapped to the wrong company, or anything that looks off on the site, say it in the comments or DM me. I check every correction against the source and fix it in the database. Same if something on the site is confusing or missing, I'd rather hear it here.

Disclaimer: not financial advice. This is a calendar and a summary of public company announcements, nothing more. Dates move, the FDA can act early or late, and I can still get things wrong. Check the company's press release, its SEC filings or FDA.gov before relying on any of it.

November decisions, each with its source: catalystalert.io/pdufa/november-2026

Full calendar and dossiers: catalystalert.io

What does everyone think about companies like GENB and IAM?

Of course IAM IPO’d today, I’m invested in GENB. Companies like NVIDIA are invested based on creating more demand in chips/GPU’s. That’s not to say they don’t believe in it - but seems to be the main driver for now.

Has anyone else invested in these or alike?

Personally I think as a platform - it will be big one day.

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

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?

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.!

• 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.