Cytokinetics: data PDUFA do FDA para o NDA de aficamten definida para 26 de dezembro de 2025

The NDA for aficamten in obstructive HCM remains under FDA review with a confirmed PDUFA action date of December 26, 2025. The company held a Late Cycle Meeting with FDA on September 15, 2025, discussing REMS and post-marketing requirements, and continues to expect a differentiated label if approved.

Fatos principais

Arquivado: 5 de nov. de 2025, 21:00
Evento: Data PDUFA definida
Direção: Neutro
Empresa: CYTKCytokinetics
Ativo: aficamten
Fonte: SEC 8-K
Confiança: Com fonte
Calendário: Decisão da FDA (PDUFA) · 14 de nov. de 2026 · Positivo

Trecho da fonte

EX-99.1 2 cytk-ex99_1.htm EX-99.1 EX-99.1 CYTOKINETICS REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Interactions with FDA Progressing Towards December 26, 2025 PDUFA Date for Aficamten; U.S. Commercial Launch Preparations on Track Ex-U.S. Regulatory Reviews of Aficamten Ongoing in China and E.U. ~$1.25 Billion in Cash, Cash Equivalents and Investments as of September 30, 2025 SOUTH SAN FRANCISCO, Calif., Nov. 5, 2025 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the third quarter of 2025. “I’m pleased that our teams continue to demonstrate strong execution and sustained momentum as we approach the PDUFA date for the aficamten NDA . Our commercial preparations have been deliberate and strategic, positio

SEC 8-K