SEATTLE - Achieve Life Sciences Inc. (NASDAQ:ACHV) announced Tuesday it has transferred manufacturing of cytisinicline to Adare Pharma Solutions' facility in Vandalia, Ohio.
The company completed analytical method transfer to the U.S.-based facility and manufactured its first engineering batch at the site. This manufacturing run precedes registration and commercial-scale production.
Achieve disclosed that its third-party manufacturing facility received an Official Action Indicated classification from the U.S. Food and Drug Administration following a current Good Manufacturing Practice inspection. The observations leading to the OAI classification relate to general cGMP matters at the facility and are not specific to cytisinicline, according to a press release statement.
The company expects to receive a Complete Response Letter from the FDA on or before the June 20, 2026 Prescription Drug User Fee Act goal date. Achieve plans to resubmit its New Drug Application in the fourth quarter of 2026, naming Adare Pharma Solutions as the manufacturer for commercial supply.
The company maintains its expectation for a cytisinicline launch in the first half of 2027, pending FDA approval.
Cytisinicline is being developed as a treatment for nicotine dependence. The FDA accepted Achieve's New Drug Application for review in September 2025, based on two completed Phase 3 studies and an open-label safety study. The application seeks approval for cytisinicline as a treatment for smoking cessation in adults.
Adare Pharma Solutions is a contract development and manufacturing organization with facilities in the U.S. and Europe. Tom Sellig, Adare's Chief Executive Officer, has served on Achieve's Board of Directors since 2023.
The company cited recent tariffs on imported pharmaceutical products as a factor driving the shift to domestic manufacturing.
In other recent news, Achieve Life Sciences reported its fourth-quarter 2025 earnings, meeting the expected earnings per share (EPS) of -0.28. The company also announced that its U.S. commercial launch for cytisinicline is now planned for the first half of 2027, which is beyond the previously targeted PDUFA action date of June 20, 2026. This delay has raised some concerns among investors regarding the company's future capital needs. Meanwhile, H.C. Wainwright has reiterated a Buy rating on Achieve Life Sciences with a price target of $12.00. Jones Trading also maintained a Buy rating, setting a higher price target of $20.00. Additionally, Achieve Life Sciences published a study in Nicotine & Tobacco Research, highlighting cytisinicline's receptor selectivity profile. The research showed strong binding at the α4β2 nicotinic receptor with minimal binding at the 5-HT3 receptor, which may explain the lower incidence of nausea in smoking cessation therapy. These developments provide a comprehensive view of the company's current standing and future prospects.