Achieve Life shares rise 10.33% intraday as FDA accepts NDA for smoking cessation drug and Citizens initiates coverage with $19 target.

Achieve Life Sciences (ACHV) surged 10.33% intraday following the U.S. Food and Drug Administration’s acceptance of its New Drug Application (NDA) for cytisinicline, a smoking cessation treatment, with a PDUFA decision date set for June 20, 2026. This regulatory milestone, combined with Citizens’ initiation of coverage with a "Market Outperform" rating and a $19 price target (implying 380% upside from its $3.97 price), fueled investor optimism. Analysts highlighted cytisinicline’s differentiated profile compared to existing therapies like Chantix and a 90% estimated FDA approval probability. Despite a Q3 earnings miss and recent volatility, the stock’s rally reflected confidence in the drug’s commercial potential and the company’s robust cash reserves to support its launch.