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ACHIEVE LIFE SCIENCES INC · Data as of 2026-10-25
Upcoming catalysts
cytisinicline — NDA/BLA submission
Q4 2026
The Company intends to resubmit its NDA naming Adare as its finished drug product manufacturer for commercial supply in the fourth quarter of 2026 and anticipates potential FDA approval in the first half of 2027, with U.S. commercial launch to follow.
Source filingcytisinicline — PDUFA
H1 2027
Anticipates potential FDA approval in the first half of 2027, followed by U.S. commercial launch
Source filingcytisinicline — Conference presentation
CHEST 2026
Achieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026
Source filingExplore the free biotech catalyst calendar