Cytokinetics:aficamten NDAのFDA PDUFA日、2025年12月26日に設定

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.

主要事実

提出: 2025年11月5日 21:00
イベント: PDUFA 日設定
方向: 中立
企業: CYTKサイトキネティクス
アセット: aficamten
出典: SEC 8-K
信頼度: 出典あり
カレンダー: FDA 審査決定 (PDUFA) · 2026年11月14日 · ポジティブ

出典の抜粋

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