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As of Nov 10, 2026: The FDA's decision date for rostudirsen is Jan 21, 2027, in 72 days. Dyne Therapeutics had about eight quarters of cash at its Sep 30 balance. Dyne Therapeutics' Quality Score is -6. Scores as of 11:07 PM ET, 15 minutes behind.

Dyne Therapeutics (DYN) logo

Dyne Therapeutics (DYN) · FDA decision date (PDUFA)

Dyne Therapeutics' FDA decision on rostudirsen, a treatment for exon

PDUFA date: Jan 21, 2027, in 72 daysQuality Score: -6, Poor
Share price: $17.92, -3.76% on the day
Cash runway: 8, quarters of cash

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What the company said

“PDUFA target action date of January 21, 2027”

PDUFA date, Jan 21, 2027. As Dyne Therapeutics stated in its 8-K of Nov 5, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

Tested. Our top-scored stocks returned 2.2x the average stock over the next month. Reconstructed after the fact; recorded live since Sep 9, 2026. How we tested it

How DYN's stock moved on its past FDA days, for Pro members. Pro members also see whether its cash lasts past Jan 21, and the FDA calendar with filters and optional alerts.

More on DYN and the FDA calendar

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Kept by Andrew Gomes, Breakaway's founder, from the company's filings on the SEC's EDGAR. Updated Nov 10, 2026.

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How to cite

Breakaway, Dyne Therapeutics' FDA decision on rostudirsen, a treatment for exon, Nov 10, 2026, getbreakaway.com/biotech/DYN-rostudirsen

Journalists: email support@getbreakaway.com for the data behind this page.

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