As of Oct 26, 2026: 10 dates on the FDA calendar in November 2026, the first on Nov 1, 2026. Scores as of 7:29 PM ET, 15 minutes behind.

FDA decisions in November 2026

PDUFA dates and FDA panels

Next FDA dateNov 1AGIO, in 6 days Decision dates10in November Companies10with a date

FDA dates in November 2026

A drug's name opens its date's page

FDA decision dates and panels in November 2026, each with the company's Quality Score and cash runway
Date	Stock	Drug	Cash runway	Quality Score
November 202610
November 202610
November 202610
	AGIOAgios PharmaceuticalsMitapivat · 8-KCash: 10 quarters	MitapivatPDUFA date · in 6 days · 8-K	About 10 quartersBalance Jun 30	10
	NRXPNRX PharmaceuticalsANDA decisionCash: 5 quarters	Preservative-free…GDUFA goal date · in 15 days · 8-K	About 5 quartersBalance Jun 30	-6
	CYTKCytokineticsAficamten · 8-KCash: 12 quarters	AficamtenPDUFA date · in 19 days · 8-K	About 12 quartersBalance Jun 30	-3
	SMMTSummit TherapeuticsIvonescimab · 8-KCash: 6 quarters	IvonescimabPDUFA date · in 19 days · 8-K	About 6 quartersBalance Jun 30	-1
	CAPRCapricor TherapeuticsDeramiocel · 8-KCash: into Q4 2027	DeramiocelPDUFA date · in 27 days · 8-K	Into Q4 2027The company's words	-7
	SVRASavaraMolgramostimCash: 6 quarters	MolgramostimPDUFA date · in 27 days · 10-Q	About 6 quartersBalance Jun 30	-4
	SNYSanofiVenglustat · 6-KRunway not counted	VenglustatPDUFA date · in 30 days · 6-K	Not countedBalance Dec 2025	5
	BBIOBridgeBio PharmaBBP-418 · 8-KCash: 6 quarters	BBP-418PDUFA date · in 32 days · 8-K	About 6 quartersBalance Jun 30	4
	COGTCogent BiosciencesBezuclastinibCash: 10 quarters	BezuclastinibPDUFA date · in 35 days · 8-K	About 10 quartersBalance Jun 30	0
	VRTXVertex PharmaceuticalsPovetaciceptBrings in cash	PovetaciceptPDUFA date · in 35 days · 8-K	Brings in cashBalance Jun 30	14

Pro members also see whether each company's cash lasts past its date, how its stock moved on past FDA news, and filters by area, phase, and size, with an optional alert before each date.

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November 2026, by week

Use this page

Kept by Andrew Gomes, Breakaway's founder, from the companies' filings on the SEC's EDGAR, each date's filing linked on its row. Updated Oct 26, 2026.

Download the month's dates (PNG)Free to reuse with a link to this page.

How to cite

Breakaway, FDA decisions in November 2026, Oct 26, 2026, getbreakaway.com/biotech/2026-11

Journalists: email [email protected] for the data behind this page.

The FDA calendar.