Dyne Therapeutics: nasa tamang landas ang pagsusumite ng BLA ng z-rostudirsen para sa Q2 2026

Dyne completed a positive pre-BLA meeting with FDA and remains on track to submit a BLA for U.S. Accelerated Approval of z-rostudirsen in exon 51 DMD in Q2 2026. The company also plans to initiate a global confirmatory Phase 3 trial in Q2 2026, with potential U.S. launch targeted for Q1 2027 assuming Priority Review and approval.

Mahahalagang fact

Na-file: May 11, 2026, 11:35 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: DYNDyne Therapeutics
Asset: z-rostudirsen
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 dyn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Dyne Therapeutics Reports First Quarter 2026 Financial Results and Recent Business Highlights - Positive pre-BLA meeting completed with FDA for z-rostudirsen in exon 51 DMD; on track for BLA submission in Q2 2026 and potential launch in Q1 2027 - - Positive cardiopulmonary results and long-term dystrophin data from Phase 1/2 DELIVER trial of z-rostudirsen in exon 51 DMD presented at MDA conference - - Completion of enrollment in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in DM1 on track for Q2 2026; global confirmatory Phase 3 HARMONIA trial initiated - - New preclinical data to be presented at ASGCT underscore differentiated capability of clinically validated FORCE TM platform to cross the blood-brain

SEC 8-K