Cytokinetics: aficamten NDA PDUFA nananatili sa Disyembre 26, 2025

FDA nagdaos ng Late Cycle Meeting noong Setyembre 15, 2025 at nagbigay ng feedback tungkol sa iminungkahing REMS at label para sa aficamten. Ang PDUFA target action date para sa NDA sa obstructive hypertrophic cardiomyopathy ay nananatiling hindi nagbabago sa Disyembre 26, 2025.

Mahahalagang fact

Na-file: Set 16, 2025, 08:08 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: CYTKCytokinetics
Asset: aficamten
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Nob 14, 2026 · Positibo

Sipi mula sa source

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