PYPD
PolyPid Ltd.
stockNASDAQ

PYPD

Also bullish on PYPD

NRXP, HELP and PYPD are my plays!

Hey everyone, Dev behind [CatalystAlert.io](https://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](https://catalystalert.io/research/CAPR) or [catalystalert.io/research/SMMT](https://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](https://catalystalert.io/pdufa/november-2026) Full calendar and dossiers: [catalystalert.io](https://catalystalert.io)