Achieve Life Sciences: Maintaining 'Buy' On Upcoming PDUFA And Expansion Into Vaping Cessation

Achieve Life Sciences remains a 'Buy' as cytisinicline's NDA for smoking cessation is under FDA review with a PDUFA date of June 20, 2026. ACHV exceeded long-term safety study requirements and secured a manufacturing partnership, positioning for a potential 1H 2027 commercial launch if approved. The company plans to initiate the phase 3 ORCA-V2 trial for vaping cessation in 1H 2026, targeting a large, underserved market segment.