Natanggap ng Achieve ang CRL para sa cytisinicline NDA; muling pagsusumite planado sa Q4 2026

Naglabas ang FDA ng Complete Response Letter noong Hunyo 20, 2026, na binanggit ang mga obserbasyon sa cGMP sa dating third-party manufacturing site at hindi kumpletong product labeling. Walang natukoy na kakulangan sa clinical efficacy o safety. Lumilipat ang Kumpanya sa finished-drug manufacturing patungo sa Adare Pharma Solutions at planong muling pagsumite ng NDA sa Q4 2026 na may potensyal na pag-apruba sa H1 2027.

Mahahalagang fact

Na-file: Ago 11, 2026, 08:04 PM
Kaganapan: Complete response letter
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 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