Dyne: Tinanggap ng FDA ang BLA para sa z-rostudirsen; itinakda ang PDUFA sa Enero 21, 2027

Tinanggap ng FDA ang BLA para sa z-rostudirsen at binigyan ito ng Priority Review. Ang target na petsa ng aksyon ng PDUFA ay ngayon Enero 21, 2027, na nagtatatag ng matatag na timeline ng regulasyon para sa potensyal na pag-apruba sa U.S.

Mahahalagang fact

Na-file: Hul 29, 2026, 08:35 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: DYNDyne Therapeutics
Asset: z-rostudirsen
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ene 21, 2027 · Positibo

Sipi mula sa source

EX-99.1 2 dyn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Dyne Therapeutics Reports Second Quarter 2026 Financial Results and Recent Business Highlights - Biologics License Application (BLA) for z-rostudirsen in exon 51 DMD accepted for review by FDA; Priority Review granted; PDUFA target action date set for January 21, 2027 - - Completed enrollment of 71 participants in registrational expansion cohort of Phase 1/2 ACHIEVE trial of z-basivarsen in DM1; topline data planned for Q1 2027 - - Investigational New Drug (IND) Application cleared by FDA for DYNE-302 in FSHD - - Expected cash runway into Q2 2028 - WALTHAM, Mass., July 29, 2026 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neur

SEC 8-K