Achieve Life Sciences, Inc.·Healthcare

Achieve Life Sciences is rated Buy for risk-tolerant investors after a sharp sell-off tied to FDA manufacturing concerns. Cytisinicline demonstrates strong efficacy and a superior safety profile versus Chantix, supporting blockbuster potential in smoking cessation. Manufacturing issues prompted a supplier switch to Adare Pharma; FDA approval probability is estimated at 35% on the first try, rising to 70% if resubmitted.

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.

SEATTLE and VANCOUVER, British Columbia, March 26, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced the publication of a manuscript in Nicotine & Tobacco Research describing the receptor selectivity profile of cytisinicline. This study provides mechanistic characterization of cytisinicline's receptor selectivity profile, which informs understanding of its favorable tolerability.

Achieve Life Sciences, Inc. (ACHV) Q4 2025 Earnings Call Transcript

San Diego, California--(Newsfile Corp. - March 24, 2026) - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of Achieve Life Sciences, Inc. (NASDAQ: ACHV). The investigation focuses on Achieve Life Sciences executive officers and whether investor losses may be recovered under federal securities laws.

Achieve also Announces Partnership with U.S.-based Adare Pharma Solutions for Cytisinicline Manufacturing Conference Call Scheduled for 8:30 AM EDT Today, March 24, 2026 SEATTLE and VANCOUVER, British Columbia, March 24, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced financial results for the fourth quarter and full year 2025 and provided updates on the cytisinicline development program, including the announcement of its partnership with Adare Pharma Solutions (Adare). “Achieve is fully committed to bringing cytisinicline to the millions of people who continue to struggle with nicotine dependence and need a new solution to help them quit.
Achieve Life Sciences, Inc., a clinical-stage pharmaceutical company, develops and commercializes of cytisinicline for smoking cessation and nicotine addiction in Canada, the United States, and the United Kingdom. The company offers cytisinicline, a plant-based alkaloid that interacts with nicotine receptors in the brain that reduce the severity of nicotine withdrawal symptoms. It has license agreements with Sopharma AD and University of Bristol. The company is based in Vancouver, Canada.
Healthcare
Biotechnology
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1995-10-12
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