Q3 2026 FDA Calendar: Every PDUFA Date to Track

The FDA doesn’t care about your feelings. It cares about the calendar. Every PDUFA date on the FDA’s schedule is a binary catalyst that can move a biotech stock 30 to 80% in a day. If you are not tracking those dates 2 to 6 weeks ahead, you are trading blind.

Last updated August 4, 2026: REPL RP1 PDUFA (August 2, Sunday) — no FDA decision as of August 4 (pre-market Tuesday). REPL closed at $11.91 on August 3 (Polygon), up 6.3% from $11.20 on July 31. The stock traded $10.13-$12.60 on Monday. NVO Mim8 PDUFA (July 29) is now 4 business days overdue — Drugs.com still lists “FDA Approved: No.” NVO closed at $47.09 on August 3 (Polygon), flat from $47.08 on July 31. MRNA closed at $55.14 on August 3, PDUFA August 5 (tomorrow). AZN fell 6.9% to $157.97 on Monday on BMY merger concerns.

This is the complete Q3 2026 (July through September) FDA calendar, with every confirmed PDUFA date, the outcome where the decision has already landed, and the five catalysts most likely to move the sector. For the mechanics of what a PDUFA date is and how the FDA sets review timelines, see our PDUFA date guide.

Q3 2026 PDUFA calendar

Date	Ticker	Drug	Indication	App Type	Review	Status
Jul 7	VERA	Trutakna (atacicept)	IgA nephropathy	BLA	Priority	Approved
Jul 7	MRK	ENHERTU (T-DXd)	HER2+ early breast cancer	sBLA	Priority	Approved
Jul 11	CORT	relacorilant (Lifyorli)	platinum-resistant ovarian cancer	NDA	Standard	Approved (Mar 25, 3.5 mo early)
Jul 14	CELC	gedatolisib (Revtorpyk)	HR+/HER2- breast cancer	NDA	Priority	Approved (3 days early)
Jul 23	HEL	rivoceranib + camrelizumab	unresectable hepatocellular carcinoma	NDA	Standard	CRL
Jul 26	MNKD	FUROSCIX ReadyFlow	edema (CHF/CKD)	sNDA	Standard	Approved
Jul 29	CAPR	deramiocel (AdCom)	Duchenne muscular dystrophy	BLA	n/a	AdCom: 9-3 against
Jul 29	NVO	Mim8 (denecimig)	hemophilia A prophylaxis	BLA	Priority	Pending
Jul 30	VTRS	MR-100A-01 (Gwyn Lo)	contraceptive patch	NDA	Standard	Approved (Jul 29, 1 day early)
Jul 30	REPL	RP1 + nivolumab (AdCom)	advanced melanoma (post-PD-1)	BLA	Priority	AdCom: 10-3 in favor
Aug 2	REPL	RP1 + nivolumab	advanced melanoma (post-PD-1)	BLA	Priority	Pending
Aug 5	MRNA	mRNA-1010	seasonal flu vaccine	BLA	n/a	Pending
Aug 13	NVS	Pluvicto (177Lu-PSMA-617)	PSMA+ metastatic hormone-sensitive prostate cancer	sBLA	Priority	Approved (Jul 31, 13 days early)
Aug 22	CAPR	deramiocel	Duchenne muscular dystrophy cardiomyopathy	BLA	Priority	Pending
Aug 22	SVRA	MOLBREEVI (molgramostim)	autoimmune pulmonary alveolar proteinosis	BLA	Priority	Pending (extended to Nov 22)
Aug 25	JAZZ	Ziihera (zanidatamab)	HER2+ gastric/GEJ cancer (1L)	sBLA	Priority	Pending
Aug 27	GILD	BIC/LEN (bictegravir + lenacapavir)	HIV (virologically suppressed adults)	NDA	Priority	Pending
Sep 18	NUVL	zidesamtinib	ROS1+ NSCLC (TKI pre-treated)	NDA	Priority	Pending
Sep 19	RARE	UX111 (AAV gene therapy)	Sanfilippo syndrome type A (MPS IIIA)	BLA	Priority	Pending
Sep 22	IONS	zilganersen	Alexander disease	NDA	Priority	Pending

Note: Ionis (IONS) olezarsen (Tryngolza) for severe hypertriglyceridemia was approved June 24, 2026, ahead of its June 30 PDUFA. It is not listed in the Q3 table but is included here for completeness. Keytruda QLEX (subcutaneous pembrolizumab) was approved September 19, 2025 for most solid tumor indications; any August 17 sNDA would be for an expanded label.

July outcomes: what already happened

Eight Q3 PDUFA dates have already landed. The results illustrate the binary nature of biotech catalysts.

Approved: Vera Therapeutics (VERA) received accelerated approval for Trutakna in IgA nephropathy on July 7. The same day, Merck’s ENHERTU (MRK) cleared its sBLA for HER2-positive early breast cancer. Celcuity (CELC) got the call three days before its July 17 PDUFA, with Revtorpyk (gedatolisib) approved July 14 for PIK3CA wild-type HR+/HER2- breast cancer. Corcept Therapeutics (CORT) secured approval for Lifyorli (relacorilant) on March 25, 3.5 months ahead of its July 11 PDUFA, for platinum-resistant ovarian cancer. MannKind (MNKD) secured approval for the FUROSCIX ReadyFlow autoinjector on July 24, two days ahead of its July 26 PDUFA. Viatris (VTRS) received approval for Gwyn Lo on July 29, one day ahead of its July 30 PDUFA, for a low-dose estrogen weekly contraceptive patch. Novartis (NVS) received approval for Pluvicto on July 31, 13 days ahead of its August 13 PDUFA, for PSMA+ metastatic hormone-sensitive prostate cancer.

CRL: Elevar Therapeutics (HEL) received a third Complete Response Letter for rivoceranib plus camrelizumab in hepatocellular carcinoma on July 10. The combination was previously approved in China, but the FDA rejected the U.S. application over manufacturing deficiencies. For what a CRL does to a stock and why the base rate is 37% of all applications, see our CRL guide.

Still pending: Novo Nordisk (NVO) had a July 29 PDUFA for Mim8 (denecimig) in hemophilia A — as of August 4, still no FDA announcement (4 business days overdue, the longest delay in Q3 2026). The FDA may issue a delayed approval, a CRL, or request additional information. Drugs.com still lists Mim8 as “FDA Approved: No.” NVO closed at $47.09 on August 3 (Polygon).

AdComm votes: The CTGTAC voted 9-3 against Capricor’s (CAPR) deramiocel for DMD cardiomyopathy on July 29, siding with FDA staff that the HOPE-3 trial did not provide substantial evidence of effectiveness. The August 22 PDUFA now leans toward rejection. See our full AdComm coverage. The same committee meets July 30 to vote on Replimune’s (REPL) RP1 in melanoma — FDA briefing docs called the IGNYTE study “not interpretable.” See our RP1 briefing docs coverage.

Approved (late July): Viatris (VTRS) received FDA approval for Gwyn Lo on July 29, one day ahead of its July 30 PDUFA. See our Gwyn Lo approval coverage.

The 5 highest-impact catalysts still ahead

These are the dates most likely to move sector ETFs, not just individual stocks.

1. Replimune (REPL), August 2. RP1 plus nivolumab in advanced melanoma, third BLA resubmission after two CRLs (July 2025 and April 2026). The FDA scheduled an AdCom for late July ahead of the PDUFA. An AdCom vote is the pre-signal: positive vote runs the stock into August 2; negative vote drops it before the PDUFA. See our REPL RP1 melanoma coverage for the full background.

2. Gilead (GILD), August 27. BIC/LEN is a once-daily single-tablet HIV regimen combining bictegravir with lenacapavir, a first-in-class capsid inhibitor. Priority review. If approved, this becomes a new option for virologically suppressed adults and extends Gilead’s HIV franchise. A large-cap catalyst with sector-wide read-through for HIV competitors.

3. Ultragenyx (RARE), September 19. UX111 is an AAV gene therapy for Sanfilippo syndrome type A (MPS IIIA), a devastating rare pediatric disease with no approved treatments. Priority review on a resubmission after an earlier CRL. Gene therapy approvals move the entire rare disease and gene therapy sector because they validate the platform.

4. Nuvalent (NUVL), September 18. Zidesamtinib is a ROS1-selective inhibitor for previously treated ROS1-positive non-small cell lung cancer. Breakthrough therapy designation. A precision oncology approval that would establish Nuvalent as a commercial-stage company.

5. Ionis (IONS), September 22. Zilganersen for Alexander disease, a rare and often fatal neurological condition with no treatment. Priority review. If approved, it would be the first disease-modifying therapy for AxD and a proof point for antisense oligonucleotide platforms in rare CNS diseases.

How to use this calendar

Mark dates 2 to 6 weeks out for run-up positioning. The run-up phase is where most of the move happens. For the remaining August and September dates, the entry window is now. For a systematic framework on entering, sizing, and exiting catalyst trades, see our PDUFA date guide.

Track AdCom dates as pre-signals. The Capricor (CAPR) deramiocel AdCom on July 29 is the pre-signal for a future DMD BLA decision. A positive vote runs the stock; a negative vote is your exit. See our CAPR deramiocel AdCom coverage for what is at stake.

Use priority review as a timing indicator. Priority review means a 6-month FDA clock versus 10 months for standard review. Every date marked “Priority” in the table above entered review faster, but priority review does not mean approval is more likely. It means the FDA agreed to move faster.

Verify every date before you trade. PDUFA dates slip. Companies file amendments that extend the clock. Cross-check any date against the company’s latest press release or BioPharmCatalyst.com before you commit capital.

Q4 2026 forward look

Beyond Q3, several major catalysts are already on the Q4 calendar:

• October 10: I-DXd BLA for extensive-stage small cell lung cancer
• November 27: BridgeBio BBP-418 (povelvertide) in limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). See our BBP-418 PDUFA analysis for the full case.
• November 30: Cogent bezuclastinib in systemic mastocytosis
• Q4 2026: Rusfertide NDA in polycythemia vera

Mark these now. The traders who position in September for Q4 catalysts capture the run-up. The traders who wait for the PDUFA headline buy the top.

Final checklist

• Q3 dates copied to your personal trading calendar
• AdCom dates flagged (CAPR July 29, REPL late July)
• Run-up entry windows identified (2 to 6 weeks before each PDUFA)
• Position sizes capped at 2 to 5% of portfolio per catalyst
• Exit plans written for approval, CRL, or delay scenarios
• Q4 dates flagged for September positioning