Achieve menerima CRL untuk NDA cytisinicline; pengajuan ulang direncanakan Q4 2026

FDA mengeluarkan Complete Response Letter pada 20 Juni 2026, mengutip observasi cGMP di lokasi manufaktur pihak ketiga sebelumnya dan pelabelan produk yang belum lengkap. Tidak ada kekurangan efikasi atau keamanan klinis yang teridentifikasi. Perusahaan sedang mengalihkan manufaktur obat jadi ke Adare Pharma Solutions dan merencanakan pengajuan ulang NDA pada Q4 2026 dengan potensi persetujuan pada H1 2027.

Fakta utama

Diajukan: 11 Agu 2026, 20.04
Peristiwa: Surat tanggapan lengkap
Arah: Negatif
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 Second Quarter 2026 Financial Results and Provides Business Updates Closed a private placement of up to $354 million, with $180 million upfront and up to $174 million from warrants exercisable prior to and up to 20 trading days following FDA approval Strengthened organization with new Chief Executive Officer, experienced commercial, CMC, and quality leaders, along with six new appointments to the Board of Directors Anticipates potential FDA approval in the first half of 2027, followed by U.S. commercial launch SEATTLE and VANCOUVER, British Columbia, August 11, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company

SEC 8-K