Z-rostudirsen is a Dyne Therapeutics, Inc. program in duchenne muscular dystrophy amenable to exon 51 skipping. Its PDUFA date is Jan 21, 2027, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Duchenne muscular dystrophy amenable to exon 51 skipping. Sponsor: Dyne Therapeutics, Inc. (DYN). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 3,235,684 | $71.9 million | filed August 14, 2026 |
| Perceptive Advisors | 2,689,235 | $59.7 million | filed August 14, 2026 |
| Baker Bros. Advisors | 813,449 | $18.1 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Z-rostudirsen's PDUFA date is Jan 21, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for Z-rostudirsen is in our archive yet.
In our records Z-rostudirsen is under review or in development for Duchenne muscular dystrophy amenable to exon 51 skipping.
Dyne Therapeutics, Inc. (DYN).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.