z-basivarsen ACHIEVE is a Dyne Therapeutics, Inc. program in myotonic dystrophy type 1. Its next catalyst is a Readout in Q1 2027. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: myotonic dystrophy type 1. Sponsor: Dyne Therapeutics, Inc. (DYN). 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.
The next tracked catalyst for z-basivarsen ACHIEVE is a Readout in Q1 2027.
No FDA decision for z-basivarsen ACHIEVE is in our archive yet.
In our records z-basivarsen ACHIEVE is under review or in development for myotonic dystrophy type 1.
Dyne Therapeutics, Inc. (DYN).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.