When is the next FDA decision date?

The next FDA (PDUFA) decision BioRadar is tracking is MIRM on September 26, 2026, about 3 days away. There are 23 upcoming FDA decision dates in total, with 2 in the next 30 days.

What is a PDUFA date?

A PDUFA date is the FDA's target action date for deciding on a drug application, named after the Prescription Drug User Fee Act. On that date the FDA typically approves the drug, issues a Complete Response Letter (rejection), or extends the review. It is a target, not a guaranteed approval date.

How many FDA decisions are coming up in the next 90 days?

BioRadar is tracking 11 FDA (PDUFA) decision dates in the next 90 days, out of 23 upcoming decisions in total through May 2027.

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Upcoming FDA Decisions & PDUFA Dates

Every upcoming FDA drug-decision (PDUFA) date BioRadar is tracking, with approval-probability scores. Updated automatically — last refreshed September 23, 2026.

The next FDA decision is MIRM (NDA) on September 26, 2026, 3 days away. BioRadar is tracking 23 upcoming PDUFA dates — 2 in the next 30 days and 11 in the next 90 days — through May 2027.

2Next 30 days

11Next 90 days

23Total upcoming

Sep 26Next decision

A PDUFA date is the FDA's target action date for deciding on a drug application. On that date the FDA typically approves the drug, issues a Complete Response Letter (rejection), or extends the review. These are binary, high-variance catalysts — see how biotech stocks have historically moved around FDA decisions.

September 2026 (2)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Sep 26	MIRM	—	NDA	64%	3d
Sep 30	SRRK	children and adults with spinal muscular atrop	BLA	64%	7d

October 2026 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Oct 30	INO	adults with Recurrent Respiratory Papillomatos	BLA	60%	37d

November 2026 (6)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Nov 1	AGIO	—	sNDA	82%	39d
Nov 14	SMMT	EGFRm NSCLC Post-TKI Therapy BLA Filing Based	BLA	62%	52d
Nov 14	CYTK	adults with symptomatic oHCM to improve functi	sNDA	82%	52d
Nov 14	BTAI	agitation associated with Alzheimer&rsquo	sNDA	76%	52d
Nov 22	CAPR	rare diseases	BLA	50%	60d
Nov 27	BBIO	—	NDA	66%	65d

December 2026 (3)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Dec 12	VNDA	—	BLA	64%	80d
Dec 22	MLYS	hypertension in	NDA	66%	90d
Dec 23	GILD	Multiple Myeloma &ndash	BLA	61%	91d

January 2027 (2)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Jan 21	DYN	—	BLA	64%	120d
Jan 29	PRAX	SCN2A and SCN8A-DEE and RPD designation for Dr	NDA	66%	128d

February 2027 (2)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Feb 27	CGEM	—	NDA	66%	157d
Feb 28	APMD	—	NDA	66%	158d

March 2027 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Mar 10	NTLA	—	BLA	64%	168d

April 2027 (3)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Apr 1	HRMY	—	NDA	66%	190d
Apr 14	INBX	Ozekibart — Unresectable or Metastatic Conventional Chondr	BLA	59%	203d
Apr 28	IMNM	adults with desmoid tumors and assigned a PDUF	NDA	63%	217d

May 2027 (3)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
May 1	AXSM	agitation associated with dementia due to Alzh	NDA	60%	220d
May 8	BBIO	Encaleret — individuals living with autosomal dominant hyp	NDA	66%	227d
May 27	ZBIO	IgG4-RD accepted by FDA	BLA	64%	246d

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Data: SEC & FDA filings • Approval odds are model estimates, not guarantees • Informational only, not investment advice. • Past FDA decisions & outcomes →