ACHV：FDA 接受 cytisinicline 新藥申請；PDUFA 目標日期訂於 2026 年 6 月 20 日

FDA 已接受 cytisinicline 新藥申請，用於戒菸治療，並指定 PDUFA 目標行動日期為 2026 年 6 月 20 日。該公司亦宣布與 Adare Pharma Solutions 建立美國製造合作夥伴關係，以支援 2027 年上半年潛在商業上市。

關鍵事實

申報時間: 2026年3月24日上午11:05
事件: 申請已受理
方向: 正面
公司: ACHVAchieve Life Sciences
資產: cytisinicline
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2026年6月20日 · 完整回覆函 (CRL)

來源摘錄

EX-99.1 2 achv-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates Achieve also Announces Partnership with U.S.-based Adare Pharma Solutions for Cytisinicline Manufacturing Conference Call Scheduled for 8:30 AM EDT Today, March 24,2026 SEATTLE and VANCOUVER, British Columbia, March 24, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc(Achieve) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced financial results for the fourth quarter and full year 2025 and provided updates on the cytisinicline development program, including the announcement of its

SEC 8-K