Achieve Life Sciences posts corporate presentation on cytisinicline smoking-cessation program
ACHV•Corporate presentation outlines FDA approval path and launch timing
Achieve outlined a path to potential FDA approval of cytisinicline for smoking cessation, with a PDUFA date of June 20, 2026.
Commercial launch planning targets Q4 2026, with continuing launch activity projected into 1H 2027.
Financing totals up to $354 million, including $180 million upfront, with up to $174 million in milestone-driven warrants tied to FDA approval.
Late-stage and Phase 2 data support smoking and vaping cessation programs
Phase 3 pooled data showed continuous abstinence of 31.5% vs. 8.2% at weeks 9-12; odds ratio 5.3; p<0.0001.
For vaping cessation, Phase 2 ORCA-V1 reported 31.8% vs. 15.1% continuous e-cigarette abstinence at weeks 9-12; odds ratio 2.64; p=0.035.
