ACHV: Tinanggap ng FDA ang cytisinicline NDA; Itinakda ang PDUFA sa Hunyo 20, 2026

Tinanggap ng FDA ang cytisinicline NDA para sa pagtigil sa paninigarilyo at itinalaga ang target na petsa ng aksyon ng PDUFA sa Hunyo 20, 2026. Inihayag din ng kumpanya ang pakikipagtulungan sa pagmamanupaktura sa U.S. kasama ang Adare Pharma Solutions upang suportahan ang potensyal na komersyal na paglulunsad sa H1 2027.

Mahahalagang fact

Na-file: Mar 24, 2026, 11:05 AM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: ACHVAchieve Life Sciences
Asset: cytisinicline
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Hun 20, 2026 · Complete response letter

Sipi mula sa source

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