Q4 2026 FDA Calendar: 4 PDUFAs That Move Stocks

Q4 2026 has 16 confirmed PDUFA dates. That sounds like a target-rich environment for biotech investors. It is not. When you strip out the mega-cap catalysts that will not move the parent stock, the foreign-listed companies with no investable US ticker, and the private companies, you are left with four genuine small- and mid-cap binary events where approval means 30 to 50 percent upside and a CRL means 30 to 60 percent downside. Those four are where your money goes. The rest is noise.

For the full Q3 calendar with every date and status update, we track separately. This is the forward-looking Q4 playbook.

Q4 2026 PDUFA calendar

Date	Ticker	Drug	Indication	App Type	Review	Market Cap
Oct 10	MRK	I-DXd (ifinatamab deruxtecan)	2L+ ES-SCLC	BLA	Priority	$322B
Oct 20	REGN	pozelimab	VEXAS syndrome	BLA	Priority	$73B
Oct 30	INO	INO-3107	Recurrent respiratory papillomatosis	BLA	Standard	$86M
Nov 14	SMMT	ivonescimab	EGFRm NSCLC post-TKI	BLA	Standard	$10.2B
Nov 14	CYTK	aficamten (MAPLE-HCM)	oHCM monotherapy	sNDA	Standard	$10.6B
Nov 17	Private	adrabetadex	Niemann-Pick type C	NDA	Priority	N/A
Nov 22	SVRA	MOLBREEVI	Autoimmune PAP	BLA	Priority	$1.08B
Nov 25	SNY	venglustat	Type 3 Gaucher	NDA	Standard	$104B
Nov 27	BBIO	BBP-418	LGMD2I/R9	NDA	Priority	$16.4B
Nov 27	N/A	saroglitazar	Primary biliary cholangitis	NDA	Priority	N/A
Nov 30	COGT	bezuclastinib + sunitinib	GIST	NDA	Priority	$6.76B
Nov 30	VRTX	povetacicept	IgA nephropathy	BLA	Priority	$123B
Dec 12	VNDA	imsidolimab	Generalized pustular psoriasis	BLA	Standard	$312M
Dec 18	N/A	tirabrutinib	R/R PCNSL	NDA	Standard	N/A
Dec 23	GILD	anito-cel	R/R multiple myeloma	BLA	Standard	$165B
Dec 27	PRAX	relutrigine	SCN2A/SCN8A DEE	NDA	Priority	$8.1B
Dec 30	COGT	bezuclastinib (mono)	Non-advanced SM	NDA	Priority	$6.76B
Q4 2026	AZN	Ultomiris (sBLA)	IgA nephropathy	sBLA	Priority	$262B

Source: company press releases, FDA tracker, and MarketBeat FDA calendar. Prices via Polygon.

The four that actually matter

1. Cogent Biosciences (COGT) | $39.57 | Market cap $6.76B | PDUFA Nov 30 and Dec 30

Two PDUFAs, one drug, two indications. Cogent has bezuclastinib under FDA review for both GIST (in combination with sunitinib, PDUFA November 30) and non-advanced systemic mastocytosis as monotherapy (PDUFA December 30). The SUMMIT trial for non-advanced SM hit its primary endpoint with a placebo-adjusted TSS improvement of 8.91 points (p=0.0002). The proportion of patients achieving 50% TSS reduction was 34.3% on drug versus 18.1% on placebo (p=0.01). These are clean, statistically significant results in a disease with zero approved therapies.

The GIST filing is based on the PEAK trial, which earned Breakthrough Therapy Designation and Real-Time Oncology Review. Cogent at $6.76B is the largest pure-play catalyst stock in Q4. The valuation already reflects high approval odds for both indications, but the commercial launch execution is where the upside lives. If both approve, Cogent becomes a commercial-stage company with two revenue streams. If one gets a CRL, the stock drops 30% on the binary miss. We previously analyzed Cogent’s bezuclastinib GIST PDUFA and flagged it as the top-ranked catalyst in our biotech catalyst ranking.

2. Savara (SVRA) | $5.28 | Market cap $1.08B | PDUFA Nov 22

MOLBREEVI (molgramostim) is inhaled GM-CSF for autoimmune pulmonary alveolar proteinosis, an ultra-rare lung disease with zero approved therapies. The FDA extended the PDUFA from August 22 to November 22 after requesting additional data. The IMPALA-2 Phase 3 trial met its primary endpoint: DLco% improved 9.8% on drug versus 3.8% on placebo at Week 24 (estimated treatment difference 6.0%, p<0.001), with results sustained to Week 48. The SGRQ quality-of-life score showed a 6.6-point improvement at Week 24 (p=0.007). Published in NEJM in August 2025.

At $1.08B, Savara is a classic pre-revenue binary bet. Approval validates the platform and the stock re-rates on launch expectations. A CRL, which the three-month extension made marginally more likely, sends the stock down 40%+. We analyzed Savara’s MOLBREEVI PDUFA delay and concluded the data is strong enough to support approval, but the extension itself is a yellow flag.

3. Vanda Pharmaceuticals (VNDA) | $5.05 | Market cap $312M | PDUFA Dec 12

Imsidolimab is an anti-IL-36 receptor antibody for generalized pustular psoriasis, a rare, life-threatening autoinflammatory skin disease. The GEMINI trial showed 53% of patients achieved clear skin versus 13% on placebo, with zero flares in treated patients. The market is a two-player race: Boehringer’s Spevigo (spesolimab) already owns the GPP space after its 2022 approval. Vanda would be the second entrant.

At $312M market cap, Vanda is the smallest binary event in Q4. Approval probability is reasonable given the Phase 2 data, but Vanda’s commercialization capability is the question. The company has no established specialty dermatology franchise. A small sales force launching against an entrenched first mover is a hard road. The stock moves on the FDA decision, but the sustained upside depends on Vanda’s ability to execute a launch that competes with Boehringer. We covered the Vanda imsidolimab PDUFA in our breaking news coverage.

4. INOVIO (INO) | $1.04 | Market cap $86M | PDUFA Oct 30

INO-3107 is a DNA medicine for recurrent respiratory papillomatosis, a rare HPV-related disease with zero approved therapies. The FDA accepted the BLA but explicitly questioned whether INO-3107 meets the eligibility criteria for the accelerated approval pathway in its acceptance letter. That is a red flag. When the FDA flags a pathway concern before review even starts, the approval probability drops materially.

At $86M market cap, INOVIO is the smallest company on this calendar. The stock is a penny-stock binary event. If the FDA approves, the stock doubles or triples. If the FDA issues a CRL over the accelerated approval pathway, the stock is at risk of a significant decline. We covered the INO-3107 PDUFA and the FDA’s pathway concerns. This is a high-risk, high-reward spec, not a core position.

Mega-cap catalysts: real drugs, immaterial stock moves

Several Q4 PDUFAs involve excellent drugs at companies where the stock will not move on the decision. Merck I-DXd (PDUFA October 10) is the first B7-H3-directed ADC for second-line extensive-stage small cell lung cancer. The IDeate-Lung01 Phase 2 trial showed a 48.2% confirmed ORR and 10.3-month median OS. At MRK’s $322B market cap, this drug’s peak sales of $500M to $1B are a rounding error. The stock will not react.

Regeneron pozelimab (PDUFA October 20) for VEXAS syndrome is the first targeted therapy for a devastating autoinflammatory disease. REGN at $73B will not move on this approval. Vertex povetacicept (PDUFA November 30) for IgA nephropathy is a potential best-in-class BAFF/APRIL dual inhibitor with 52% proteinuria reduction in RAINIER. VRTX at $123B already prices in a franchise, not a single drug. Gilead anito-cel (PDUFA December 23) for R/R multiple myeloma is a $7.8B acquisition thesis we analyzed Gilead’s anito-cel BCMA CAR-T PDUFA in depth, but at GILD’s $165B market cap, even successful CAR-T launch is immaterial to the stock near-term.

Cytokinetics aficamten MAPLE-HCM sNDA (PDUFA November 14) is the one mega-cap-adjacent catalyst worth watching. CYTK at $10.6B is a mid-cap where the aficamten franchise matters, but the MAPLE-HCM sNDA is a label expansion (monotherapy comparison versus metoprolol) for the already-approved drug. The stock already trades on the ACACIA-HCM nHCM readout, not this sNDA.

Foreign-listed and private: real catalysts, no investable US pure play

Three Q4 catalysts involve drugs that are clinically significant but have no US-listed ticker. Zydus saroglitazar (PDUFA November 27) for primary biliary cholangitis would be the first Indian-developed novel drug approved in the US. Zydus trades on the National Stock Exchange of India. Deciphera/ONO tirabrutinib (PDUFA December 18) for relapsed CNS lymphoma involves a company acquired by ONO Pharmaceutical, which trades on the Tokyo Stock Exchange. Beren Therapeutics adrabetadex (PDUFA November 17) for Niemann-Pick type C is a private public benefit corporation. We covered the Beren adrabetadex extension but cannot run valuation analysis without a ticker. The Sanofi venglustat PDUFA on November 25 is a classic large-cap immateriality story we already analyzed.

Verdict: ranked by risk-reward

Ranking the investable US-listed catalysts by risk-reward for Q4:

1. COGT bezuclastinib dual PDUFA (Nov 30 + Dec 30): Clean data (SUMMIT p=0.0002), clearest path to two revenue streams, $6.76B cap already prices in approval but not full launch execution. Buy ahead of the GIST decision, hold through the SM decision.

2. SVRA MOLBREEVI (Nov 22): Clean Phase 3 data published in NEJM, zero competition, but the three-month extension is a yellow flag. At $1.08B, a CRL hurts more than approval helps. Sized as a speculation, not a core holding.

3. PRAX relutrigine (Dec 27): First therapy for SCN2A/SCN8A DEE, Priority Review, Rare Pediatric Disease designation with a Priority Review Voucher on approval. At $8.1B, PRAX is pricing in approval plus a broader CNS pipeline. The three-month extension from September 27 is a concern but the drug targets an underserved pediatric population.

4. VNDA imsidolimab (Dec 12): Good Phase 2 data, but second-to-market behind Spevigo in a two-drug market. Vanda’s commercial capability is unproven. Approval is a binary event but the post-approval commercial path is harder than the FDA decision.

5. INO INO-3107 (Oct 30): The FDA flagged the accelerated approval pathway concern. Highest risk on the calendar. A $86M market cap means the stock can double or lose half its value on the decision. Pure speculation.

The rest of Q4 is mega-cap noise, foreign-listed drugs with no US pure play, or private companies. If you are positioning for Q4 biotech catalysts, the four names above are where the binary risk-reward actually lives. The other 12 dates are for your calendar, not your portfolio.