ACHV Achieve Life Sciences

Achieve receives CRL for cytisinicline NDA; resubmission planned Q4 2026

FDA issued a Complete Response Letter on June 20, 2026, citing cGMP observations at the prior third-party manufacturing site and incomplete product labeling. No clinical efficacy or safety deficiencies were identified. The Company is transitioning finished-drug manufacturing to Adare Pharma Solutions and plans NDA resubmission in Q4 2026 with potential approval in H1 2027.

Achieve Life Sciences, Inc. · complete response letter (NDA 218995)

FDA issued a complete response letter for NDA 218995 dated 2026-06-20.

Achieve Life Sciences expects FDA CRL on cytisinicline NDA by June 20, 2026

The document states that the prior third-party manufacturer received an OAI classification, leading the company to expect a Complete Response Letter on or before the June 20, 2026 PDUFA date. Achieve plans to resubmit the NDA in Q4 2026 with Adare Pharma Solutions as the new primary manufacturing partner, targeting U.S. commercial launch in H1 2027.

ACHV: FDA accepts cytisinicline NDA; PDUFA set for June 20, 2026

The FDA has accepted the cytisinicline NDA for smoking cessation and assigned a PDUFA target action date of June 20, 2026. The company also announced a U.S. manufacturing partnership with Adare Pharma Solutions to support potential commercial launch in H1 2027.

Achieve Life Sciences: FDA accepts cytisinicline NDA; PDUFA June 20, 2026

FDA accepted the cytisinicline NDA for smoking cessation in adults. The agency assigned a PDUFA target action date of June 20, 2026. The NDA is supported by Phase 3 ORCA-2 and ORCA-3 data plus long-term safety exposure exceeding FDA thresholds.