Inaasahan ng Achieve Life Sciences ang FDA CRL sa cytisinicline NDA sa Hunyo 20, 2026

Nakasaad sa dokumento na ang dating third-party manufacturer ay nakatanggap ng OAI classification, na nagdulot sa kompanya na asahan ang Complete Response Letter sa o bago ang June 20, 2026 PDUFA date. Plano ng Achieve na muling isumite ang NDA sa Q4 2026 kasama ang Adare Pharma Solutions bilang bagong primary manufacturing partner, na nagta-target ng U.S. commercial launch sa H1 2027.

Mahahalagang fact

Na-file: May 12, 2026, 11:20 AM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Negatibo
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 d854692dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Achieve Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Updates Closed Private Placement of Up to $354 Million, Including $180 Million Upfront and $174 Million in Milestone-Driven Warrants Appoints New CEO and Expands Board of Directors Advances U.S.-based Manufacturing Transition & Partnership Conference Call Scheduled for 8:30 AM EDT Today, May 12, 2026 SEATTLE and VANCOUVER, British Columbia, May 12, 2026 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the f

SEC 8-K