FDA Calendar 2026

The complete biotech catalyst calendar: PDUFA dates (FDA decision deadlines), clinical trial readouts, and advisory committee meetings. Last updated: July 23, 2026. A PDUFA date is the deadline Congress set for the FDA to act on a drug application — it's the most predictable catalyst in biotech.

What is a PDUFA date? The Prescription Drug User Fee Act date is the deadline by which the FDA must complete its review of a drug application (BLA or NDA). It's not a guarantee of approval — but it's a guarantee of a decision. Binary risk, binary reward.

🗓️ Upcoming PDUFA Dates

Date	Company	Drug / Candidate	Indication	What to Watch
Aug 14, 2026	Madrigal Pharmaceuticals MDGL	Resmetirom (THR-β agonist)	MASH / NASH	First oral therapy for MASH with F2/F3 fibrosis. Approval would be paradigm-shifting.
Aug 30, 2026	Vertex Pharmaceuticals VRTX	Suzetrigine (VX-548)	Moderate-to-severe acute pain	Non-opioid analgesic. Breakthrough Therapy designation. Could redefine pain management.
Sep 12, 2026	CRISPR Therapeutics CRSP	CTX112 (CAR-T)	B-cell malignancies (relapsed/refractory)	Next-gen CAR-T with enhanced potency. Fast Track designation.
Sep 28, 2026	Alnylam Pharmaceuticals ALNY	Cemdisiran	Complement-mediated diseases	RNAi therapeutic targeting C5. Phase 3 data in PNH showed transfusion independence.
Oct 5, 2026	Gilead Sciences GILD	Trodelvy (sacituzumab govitecan)	HR+/HER2- metastatic breast cancer	TROP2 ADC. Confirmatory TROPiCS-02 data under FDA review. Expanded label.
Oct 20, 2026	Biogen BIIB	Zauratigene cepidar (gene therapy)	SMA (type 2/3)	One-time IV gene therapy for spinal muscular atrophy. Competes with Spinraza.
Nov 3, 2026	Regeneron REGN	Dupixent (dupilumab)	COPD (eosinophilic)	Expanded label into COPD. Phase 3 BOREAS and NOTUS both met primary endpoints.
Nov 15, 2026	Moderna MRNA	mRNA-4157 (personalized cancer vaccine)	Melanoma (adjuvant, combo with Keytruda)	Phase 2 data showed 44% RFS reduction. Breakthrough Therapy. Phase 3 ongoing.
Dec 1, 2026	BioNTech BNTX	BNT122 (autogene cevumeran)	Pancreatic cancer (adjuvant)	Individualized neoantigen mRNA vaccine. Phase 1 showed durable T-cell responses.
Dec 10, 2026	Novavax NVAX	NVX-CoV2601 (updated COVID vaccine)	COVID-19 (2026-2027 season)	Protein-based vaccine. Competing with mRNA platforms for seasonal market share.

🔬 Clinical Trial Milestones

Upcoming clinical data readouts. Phase 3 is the make-or-break stage; Phase 1 data can move stocks if safety and early efficacy surprise.

Company	Drug / Candidate	Phase	Indication	Expected Data	What to Watch
Editas Medicine EDIT	EDIT-301 (reni-cel)	Phase 1/2	Sickle cell disease	Q3 2026	Updated hematopoietic stem cell data. Quick comparison vs. Casgevy (Vertex/CRISPR).
Moderna MRNA	mRNA-1345 (mRESV)	Phase 3	RSV (pediatrics)	Q3 2026	First RSV vaccine for infants under 2. mRESV showed 83.7% efficacy in adults.
Vertex Pharmaceuticals VRTX	Vanzacaftor triple combo	Phase 3	Cystic fibrosis (F508del non-GM)	Q4 2026	Would expand eligible CF population by ~5%. Potential blockbuster label expansion.
Alnylam Pharmaceuticals ALNY	Nucapsiran	Phase 2	Hypertension	Q4 2026	RNAi targeting angiotensinogen. Quarterly dosing could disrupt the hypertension market.
CRISPR Therapeutics CRSP	CTX131 (CAR-T)	Phase 1	Solid tumors	Q4 2026	First-in-human data for solid tumor CAR-T. Early signal on safety and trafficking is key.
Regeneron REGN	Linvoseltamab	Phase 3	Relapsed/refractory multiple myeloma	Q3 2026	BCMAxCD3 bispecific. Competing with J&J Tecvayli and Pfizer Elrexfio. BLA filed.
Gilead Sciences GILD	Lenacapavir	Phase 3	HIV PrEP (twice-yearly)	Q4 2026	Twice-yearly injectable for HIV prevention. PURPOSE 2 trial showed 100% efficacy.

🏛️ Advisory Committee Meetings

FDA advisory committees are panels of outside experts who vote on whether a drug should be approved. The FDA usually follows their recommendation — but not always.

Date	Committee	Drug	Ticker	Key Questions
Aug 21, 2026	Oncologic Drugs Advisory Committee (ODAC)	Madrigal Resmetirom	MDGL	Advisory committee to review risk-benefit for first-in-class MASH drug. Cardiac safety signals in focus.
Sep 18, 2026	Anesthetic and Analgesic Drug Products (AADPAC)	Vertex Suzetrigine	VRTX	Panel review of non-opioid acute pain analgesic. Abuse potential assessment expected.
Oct 10, 2026	Cellular, Tissue, and Gene Therapies (CTGTAC)	CRISPR CTX112	CRSP	Review of next-gen CAR-T manufacturing and cytokine release syndrome management.
Nov 7, 2026	Vaccines and Related Biological Products (VRBPAC)	Moderna mRNA-4157	MRNA	First-ever personalized cancer vaccine panel review. Manufacturing consistency is a key question.
Dec 5, 2026	ODAC	Gilead Trodelvy (HR+/HER2-)	GILD	Confirmatory TROPiCS-02 benefit review. Overall survival and subgroup consistency in focus.

Get calendar alerts by email

Calendar compiled from FDA filings, company press releases, and ClinicalTrials.gov. Dates are subject to change — companies can announce delays or extensions at any time. Not investment advice.