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 September 4, 2026: Ionis’s ZANVASTRO (zilganersen) was approved September 3 — the first disease-modifying treatment for Alexander disease, roughly three weeks ahead of its September 22 PDUFA (see our ZANVASTRO coverage). Twenty-four Q3 outcomes landed (22 approved, 2 CRL). NVO Mim8 now 27 business days past its July 29 PDUFA — the longest Q3 delay by far. Still pending: NVO Mim8, CAPR deramiocel (now Nov 22), SVRA MOLBREEVI (extended to Nov 22), MIRM zilurgisertib (Sep 26), Elevar lirafugratinib (Sep 27), SRRK apitegromab (Sep 30), and RARE UX111 (Sep 19).

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	Elevar	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 (27 business days past)
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	Approved (Aug 6)
Aug 5	MRNA	mRNA-1010	seasonal flu vaccine	BLA	n/a	Approved
Aug 13	NVS	Pluvicto (177Lu-PSMA-617)	PSMA+ metastatic hormone-sensitive prostate cancer	sBLA	Priority	Approved (Jul 31, 13 days early)
Aug 13	LNTH	TAUKLARIFY (florquinitau F 18)	tau PET imaging (Alzheimer’s disease)	NDA	Standard	Approved (Aug 14, 1 day late)
Aug 17	BMY	iberdomide (Zenbexus)	relapsed/refractory multiple myeloma	NDA	Priority	Approved (Aug 13, 4 days early)
Aug	REGN	garetosmab (Pasatru)	fibrodysplasia ossificans progressiva (FOP)	BLA	Priority	Approved (Aug 19)
Aug 22	CAPR	deramiocel	Duchenne muscular dystrophy cardiomyopathy	BLA	Priority	Pending (extended to Nov 22, confirmed Aug 24 — major amendment, upper-limb-only claim)
Aug 22	SVRA	MOLBREEVI (molgramostim)	autoimmune pulmonary alveolar proteinosis	BLA	Priority	Pending (extended to Nov 22)
Aug 23	RARE	Genglycos (DTX401)	glycogen storage disease type Ia (GSD1a)	BLA	Priority	Approved (Aug 19, 4 days early)
Aug 24	JNJ	IMAAVY (nipocalimab)	warm autoimmune hemolytic anemia	BLA	Priority	Approved (Aug 24)
Aug 25	JAZZ	Ziihera (zanidatamab)	HER2+ gastric/GEJ cancer (1L)	sBLA	Priority	Approved (Aug 25)
Aug 26	GSK	Tivicay PD (dolutegravir)	HIV in newborns (birth–4 weeks)	sNDA	Priority	Approved (Aug 26)
Aug 27	GILD	BIC/LEN (bictegravir + lenacapavir)	HIV (virologically suppressed adults)	NDA	Priority	Approved (Aug 27)
Aug 28	PTGX	MIMRYLO (rusfertide)	polycythemia vera (erythrocytosis)	NDA	Priority	Approved (Aug 28)
Aug 28	ITM	177Lu-edotreotide (ITM-11)	gastroenteropancreatic neuroendocrine tumors	NDA	Standard	CRL (Aug 7, CMC/manufacturing)
Aug 30	PharmaEssentia	BESREMi (ropeginterferon)	essential thrombocythemia	sBLA	Standard	Approved (Aug 31)
Sep 18	GSK	Jideytro (zidesamtinib)	ROS1+ NSCLC (TKI pre-treated)	NDA	Priority	Approved (Jul 22, ~2 months early)
Sep 19	RARE	UX111 (AAV gene therapy)	Sanfilippo syndrome type A (MPS IIIA)	BLA	Priority	Pending
Sep 22	IONS	zilganersen	Alexander disease	NDA	Priority	Approved (Sep 3, ~3 weeks early)
Sep 26	MIRM	zilurgisertib	fibrodysplasia ossificans progressiva (FOP)	NDA	Priority	Pending
Sep 27	Elevar	lirafugratinib	FGFR2+ cholangiocarcinoma	NDA	Priority	Pending
Sep 30	ROIV	brepocitinib (LISRAYA)	dermatomyositis	NDA	Priority	Approved (Aug 27, ~5 weeks early)
Sep 30	SRRK	apitegromab	spinal muscular atrophy (add-on to SMN therapy)	BLA	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

Twenty-four 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. GSK received approval for Jideytro (zidesamtinib) on July 22, 2026 — two months ahead of its September 18 PDUFA — for previously treated ROS1-positive non-small cell lung cancer, the first lung cancer approval for GSK following its $10.6 billion acquisition of Nuvalent (see our Jideytro coverage). 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. Moderna (MRNA) received approval for mFlusiva (mRNA-1010) on August 5, the first mRNA-based seasonal influenza vaccine licensed in the US, for adults 50 and older. Replimune (REPL) received accelerated approval for Tudriqev (RP1) on August 6, 2026 — the first oncolytic virus immunotherapy approved for melanoma, in combination with nivolumab, for patients who progressed on anti-PD-1 therapy. Approval came 4 business days after the August 2 (Sunday) PDUFA date and followed a 10-3 favorable AdComm vote. Bristol Myers Squibb (BMY) received accelerated approval for iberdomide (Zenbexus) on August 13, 2026 — four days ahead of its August 17 PDUFA — in combination with daratumumab and dexamethasone for relapsed/refractory multiple myeloma, the first cereblon E3 ligase modulator (CELMoD) approval. Lantheus (LNTH) received approval for TAUKLARIFY (florquinitau F 18) on August 14, one day after its August 13 PDUFA — the second tau PET imaging agent ever cleared for Alzheimer’s disease. Ultragenyx (RARE) received accelerated approval for Genglycos (DTX401) on August 19, four days ahead of its August 23 PDUFA, the first gene therapy for glycogen storage disease type Ia. Regeneron (REGN) received approval for Pasatru (garetosmab) on August 19 for fibrodysplasia ossificans progressiva, the first FOP drug shown in a placebo-controlled trial to reduce both new heterotopic ossification lesions and flare-ups. Johnson & Johnson (JNJ) received approval for IMAAVY (nipocalimab-aahu) on August 24, the first-ever therapy for warm autoimmune hemolytic anemia (see our IMAAVY coverage). Jazz Pharmaceuticals (JAZZ) received approval for Ziihera (zanidatamab-hrii) on its August 25 PDUFA for first-line HER2-positive gastroesophageal adenocarcinoma, the first bispecific HER2-targeted antibody cleared in the front-line GEA setting (see our Ziihera coverage). GSK’s ViiV Healthcare received approval for Tivicay PD (dolutegravir) on August 26, the first HIV drug cleared for newborns from birth to four weeks (see our Tivicay PD coverage). Roivant (ROIV) received approval for LISRAYA (brepocitinib) on August 27 — roughly five weeks ahead of its September 30 PDUFA — the first targeted therapy for dermatomyositis (see our LISRAYA coverage). Gilead Sciences (GILD) received approval for Bixlenvo (bictegravir/lenacapavir) on August 27, 2026, on its PDUFA date — the first and only once-daily single-tablet regimen for virologically suppressed adults with HIV on complex regimens (see our Bixlenvo coverage). Protagonist Therapeutics (PTGX) received approval for MIMRYLO (rusfertide) on August 28, 2026, for erythrocytosis in polycythemia vera — the first hepcidin mimetic ever cleared (see our MIMRYLO coverage). PharmaEssentia received approval for BESREMi (ropeginterferon alfa-2b-njft) on August 31, 2026, for essential thrombocythemia — the first new ET drug in nearly three decades (see our BESREMi coverage). Ionis Pharmaceuticals (IONS) received approval for ZANVASTRO (zilganersen) on September 3 — roughly three weeks ahead of its September 22 PDUFA — the first disease-modifying treatment for Alexander disease and the first therapy to directly target the GFAP protein buildup that drives it (see our ZANVASTRO coverage).

CRL: Elevar Therapeutics (a majority-owned subsidiary of HLB Co., not US-listed) 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. ITM (Isotope Technologies Munich) received a Complete Response Letter for 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors on August 7, 2026 — three weeks ahead of its August 28 PDUFA — citing chemistry, manufacturing, and controls (CMC) items and a third-party facility inspection, with no clinical, nonclinical, or safety concerns. The Phase 3 COMPETE win still stands and ITM intends to resubmit. See our edotreotide CRL coverage. 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 September 4, 27 business days overdue and the longest delay in Q3 2026 by far. 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 $47.51 on September 3 (Polygon). The stock continues to be driven by GLP-1 dynamics and the July 31 ZEUS/ziltivekimab Phase 3 failure rather than the Mim8 delay. Capricor (CAPR) deramiocel — the FDA confirmed on August 24 that it extended the PDUFA from August 22 to November 22, 2026, classifying Capricor’s upper-limb-only BLA amendment as a major amendment. CAPR closed at $9.89 on September 2 (Polygon). GILD BIC/LEN was approved as Bixlenvo on August 27, 2026, on its PDUFA date — see our Bixlenvo coverage.

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 — STAT News reported on August 20 that the FDA is “heading for” rejecting the therapy, calling Capricor’s submission of open-label extension data “a stall tactic.” CAPR nonetheless surged 67% after-hours on August 13 after the company outlined a “clearer regulatory path,” and on August 21 confirmed it will submit a BLA amendment narrowing deramiocel’s claim to upper-limb dysfunction only — on August 24 the FDA confirmed it extended the PDUFA to November 22, 2026, classifying the amendment as major. See our full AdComm coverage and the upper-limb amendment coverage. The same committee met July 30 and voted 10-3 in favor of Replimune’s (REPL) RP1 in melanoma — FDA briefing docs had called the IGNYTE study “not interpretable.” The FDA approved Tudriqev on August 6, 2026 — 4 business days after the August 2 (Sunday) PDUFA. REPL closed at $12.86 on August 6. See our RP1 approval 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. 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.

2. Ionis (IONS), September 22 — RESOLVED. Zilganersen was approved September 3 as ZANVASTRO, the first disease-modifying treatment for Alexander disease — a proof point for antisense oligonucleotide platforms in rare CNS diseases (see our approval coverage).

3. Mirum (MIRM), September 26. Zilurgisertib for fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease where muscle and connective tissue progressively turn to bone. Priority review. It would be the second FOP therapy after Regeneron’s Pasatru (approved August 19), differentiated by an ALK2-inhibitor mechanism.

4. Scholar Rock (SRRK), September 30. Apitegromab for spinal muscular atrophy as an add-on to SMN-targeted therapy. Priority review. A myostatin-inhibiting therapy that would be the first add-on to SMN-targeting drugs for SMA.

5. Capricor (CAPR), November 22. Deramiocel for Duchenne muscular dystrophy cardiomyopathy, narrowed to an upper-limb-only claim and extended from August 22 after the FDA classified the amendment as major. The highest-risk catalyst left this year — a 9-3 AdCom against and STAT reporting the FDA is “heading for” rejection. See our amendment coverage.

Still unresolved without a firm new date: Novo Nordisk’s Mim8 (denecimig) for hemophilia A is 27 business days past its July 29 PDUFA — the longest Q3 delay by far (see our Mim8 coverage). SVRA MOLBREEVI is extended to November 22.

Resolved and removed from this list: REPL Tudriqev (approved August 6), GILD Bixlenvo (approved August 27), NUVL/GSK Jideytro (approved July 22), and IONS ZANVASTRO (approved September 3) — all documented in the outcomes above.

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 22: Capricor deramiocel in DMD (upper-limb-only claim) — PDUFA extended from August 22 after the FDA classified Capricor’s BLA amendment as major. See our amendment coverage.
• 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
• August 28 (resolved): Rusfertide (MIMRYLO) NDA in polycythemia vera — approved August 28, 2026 as the first hepcidin mimetic. See our MIMRYLO approval coverage.

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