Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Cytisinicline is an Achieve Life Sciences Inc. program in smoking cessation of cigarettes. The FDA issued a Complete Response Letter on Jun 22, 2026. 1 FDA decision on record below. Every date links its source.
Sponsor: Achieve Life Sciences Inc. (ACHV). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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