Dyne Therapeutics Completes Enrollment for Registrational DM1 Trial, Topline Data Expected Q1 2027
DYN has more than doubled off its 52-week low of $8.06.
Summary
Dyne Therapeutics has completed enrollment for the registrational expansion cohort of its Phase 1/2 ACHIEVE trial for z-basivarsen in Myotonic Dystrophy Type 1 (DM1), enrolling 71 participants. This is a significant de-risking milestone for the investigational therapy, which holds Breakthrough Therapy and Fast Track designations. The company anticipates topline data in Q1 2027, with a potential BLA submission for U.S. Accelerated Approval in Q3 2027 and a U.S. launch in H1 2028. This progress follows the recent BLA submission for their other lead candidate, z-rostudirsen, in May.
At the time of this announcement, DYN was trading at $18.37 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.9B. The 52-week trading range was $8.06 to $25.00. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.