ACHV: FDA menerima NDA cytisinicline; PDUFA ditetapkan pada 20 Juni 2026

FDA telah menerima NDA cytisinicline untuk penghentian merokok dan menetapkan tanggal aksi target PDUFA pada 20 Juni 2026. Perusahaan juga mengumumkan kemitraan manufaktur AS dengan Adare Pharma Solutions untuk mendukung peluncuran komersial potensial pada paruh pertama 2027.

Fakta utama

Diajukan: 24 Mar 2026, 11.05
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: ACHVAchieve Life Sciences
Aset: cytisinicline
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 20 Jun 2026 · Surat tanggapan lengkap

Kutipan sumber

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