ACHV：FDA接受cytisinicline NDA；PDUFA定于2026年6月20日

FDA已接受cytisinicline NDA用于戒烟，并指定PDUFA目标行动日期为2026年6月20日。公司还宣布与Adare Pharma Solutions建立美国制造合作伙伴关系，以支持2027年上半年潜在的商业化上市。

关键事实

申报时间: 2026年3月24日 11:05
事件: 申请已受理
方向: 积极
公司: ACHVAchieve Life Sciences
资产: cytisinicline
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年6月20日 · 完整回复函 (CRL)

来源摘录

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