Achieve Life Sciences: FDA menerima NDA cytisinicline; PDUFA 20 Juni 2026

FDA menerima NDA cytisinicline untuk penghentian merokok pada dewasa. Badan tersebut menetapkan tanggal aksi target PDUFA pada 20 Juni 2026. NDA didukung oleh data Fase 3 ORCA-2 dan ORCA-3 serta paparan keamanan jangka panjang yang melebihi ambang batas FDA.

Fakta utama

Diajukan: 6 Nov 2025, 12.10
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 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