Achieve Life Sciences：FDA接受cytisinicline NDA；PDUFA日期为2026年6月20日

FDA已接受用于成人戒烟的cytisinicline NDA。该机构指定了2026年6月20日的PDUFA目标行动日期。该NDA由3期ORCA-2和ORCA-3数据以及超过FDA阈值的长期安全性暴露数据支持。

关键事实

申报时间: 2025年11月6日 12:10
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 Third Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program One of Only Nine Therapies Chosen for the Inaugural FDA Commissioner’s National Priority Voucher for E-cigarette or Vaping Cessation Conference Call Scheduled for 8:30 AM EST Today, November 6, 2025 SEATTLE and VANCOUVER, British Columbia, November 6, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (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 its financial results for third quarter 2025 and confirmed its Prescription Drug User Fee Act (PDUFA) targeted action date of June 20,

SEC 8-K