Cytisinicline - (ORCA-3)

June 22, 2026: Achieve Life Sciences, Inc. (NASDAQ: ACHV) received an FDA Complete Response Letter (CRL) for its New Drug Application (NDA) for cytisinicline for smoking cessation in adults. The CRL cites outstanding manufacturing-related observations from a cGMP inspection of a third-party manufacturing facility and notes that final product labeling was not completed by the FDA’s action date. The FDA identified no deficiencies related to cytisinicline’s clinical efficacy or safety.

The manufacturing deficiencies relate to Achieve’s prior third-party facility, which received an FDA Official Action Indicated (OAI) classification for general cGMP matters not specific to cytisinicline. Achieve had previously disclosed it expected a CRL ahead of its June 20, 2026 PDUFA date and has partnered with Adare Pharma Solutions as its new primary commercial manufacturer.

Achieve reports completion of analytical method tech transfer to Adare, successful manufacture of an engineering batch, and full qualification of testing at the site. The company plans to resubmit the NDA in Q4 2026, with potential FDA approval in 1H 2027 followed by U.S. launch. The NDA is supported by Phase 3 ORCA-2 and ORCA-3 trials and an open-label long-term safety study; long-term safety data were presented at the ATS International Conference in May 2026.