Dyne Therapeutics said it has initiated the Phase 3 HARMONIA trial evaluating zeleciment basivarsen (z-basivarsen, DYNE-101) in people aged 16 and older with myotonic dystrophy type 1. The global, randomized, placebo-controlled, double-blind study is expected to enroll about 150 participants, randomized 1:1 to receive 6.8 mg/kg z-basivarsen or placebo intravenously every eight weeks for 48 weeks, with change from baseline in the five times sit to stand test at week 49 as the primary endpoint. Dyne said the trial design and protocol were aligned with the FDA and are intended to support confirmatory evidence for traditional approval in the U.S. and ex-U.S. applications. The HARMONIA trial design will be presented in the future at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference on March 11, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Dyne Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603081801PRIMZONEFULLFEED9667919) on March 08, 2026, and is solely responsible for the information contained therein.