Cytokinetics: aficamten NDA PDUFA tetap 26 Desember 2025

FDA mengadakan Late Cycle Meeting pada 15 September 2025 dan memberikan umpan balik mengenai REMS dan label yang diusulkan untuk aficamten. Tanggal aksi target PDUFA untuk NDA pada kardiomiopati hipertrofik obstruktif tetap tidak berubah pada 26 Desember 2025.

Fakta utama

Diajukan: 16 Sep 2025, 20.08
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Netral
Perusahaan: CYTKCytokinetics
Aset: aficamten
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 14 Nov 2026 · Positif

Kutipan sumber

8-K CYTOKINETICS INC false 0001061983 0001061983 2025-09-15 2025-09-15 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): September 15, 2025 Cytokinetics, Incorporated (Exact Name of Registrant as Specified in Charter) Delaware 000-50633 94-3291317 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 350 Oyster Point Boulevard , South San Francisco , California 94080 (Address of Principal Executive Offices) (Zip Code) (650) 624-3000 (Registrant’s telephone number, including area code) Not Applicable (Former name or former address, if changed since last rep

SEC 8-K