As of Oct 26, 2026: 5 dates on the FDA calendar in September 2026: 5 approved. Scores as of 7:29 PM ET, 15 minutes behind.

FDA decisions in September 2026

PDUFA dates and FDA panels

Decision dates5in September Approved5announced FDA letters0announced

FDA dates in September 2026

With each outcome the company announced

FDA decision dates and panels in September 2026, each with the company's Quality Score and cash runway
Date	Stock	Drug	Cash runway	Quality Score
September 20265
September 20265
September 20265
	TLXApprovedTelix PharmaceuticalsApprovedRunway not counted	Drug not namedPDUFA date	Not countedBalance Dec 2025	5
	RAREApprovedUltragenyx PharmaceuticalApprovedCash: 3 quarters	UX111PDUFA date	About 3 quartersBalance Jun 30	-2
	IONSApprovedIonis PharmaceuticalsApprovedRunway not counted	Drug not namedPDUFA date	Not countedBalance Jun 30	-4
	MIRMApprovedMirum PharmaceuticalsApprovedRunway not counted	Drug not namedPDUFA date	Not countedBalance Jun 30	0
	SRRKApprovedScholar RockApprovedCash: 6 quarters	ApitegromabPDUFA date	About 6 quartersBalance Jun 30	-2

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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September 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 September 2026, Oct 26, 2026, getbreakaway.com/biotech/2026-09

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

The FDA calendar.