Dyne: FDA menerima BLA z-rostudirsen, tetapkan PDUFA 21 Jan 2027

FDA menerima BLA untuk z-rostudirsen (DYNE-251) pada DMD exon 51 skipping dan memberikan Priority Review. Tanggal aksi target PDUFA 21 Januari 2027 telah ditetapkan, selaras dengan timeline peluncuran perusahaan di AS yang direncanakan pada Q1 2027.

Fakta utama

Diajukan: 20 Jul 2026, 11.35
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: DYNDyne Therapeutics
Aset: z-rostudirsen
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 21 Jan 2027 · Positif

Kutipan sumber

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