Dyne: Tinanggap ng FDA ang z-rostudirsen BLA, itinakda ang Jan 21 2027 PDUFA

Tinanggap ng FDA ang BLA para sa z-rostudirsen (DYNE-251) sa DMD exon 51 skipping at binigyan ng Priority Review. Isang PDUFA target action date na January 21, 2027 ang itinalaga, na naaayon sa planong Q1 2027 U.S. launch timeline ng kumpanya.

Mahahalagang fact

Na-file: Hul 20, 2026, 11:35 AM
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

8-K 0001818794 false 0001818794 2026-07-20 2026-07-20 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 20, 2026 Dyne Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-39509 36-4883909 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 1560 Trapelo Road Waltham , Massachusetts 02451 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (781) 786-8230 Not applicable (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form

SEC 8-K