Achieve Life Sciences

ACHV

Market cap $189M

Adare Partnership Provides Supply Chain Redundancy and U.S.-based Manufacturing Capability Company Reiterates Guidance - If Approved, Cytisinicline Commercial Launch Expected in First Half of 2027 SEATTLE and VANCOUVER, British Columbia, April 15, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (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 significant operational progress including the transfer of cytisinicline manufacturing to U.S.-based Adare Pharma Solutions (Adare). Achieve has now completed the analytical method transfer to Adare's manufacturing facility in Vandalia, Ohio.

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.

Achieve Life Sciences Inc. (NASDAQ: ACHV) shares are up during Thursday's premarket session. Year to date, the stock has fallen around 43%.

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.

SEATTLE and VANCOUVER, British Columbia, March 17, 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 it will report its fourth quarter and full year 2025 financial results and provide a corporate update on the cytisinicline development program on Tuesday, March 24, 2026, at 8:30 AM EDT. To access the webcast, please use the following link: 4Q25 Earnings Webcast.

A pooled Phase 3 analysis of more than 1,600 people who smoke showed high quit rates; including among those who had previously not succeeded with other smoking cessation medications and regardless of the number of prior quit attempts  Late-breaking survey data from year-long ORCA-OL safety study highlight participant experience with extended cytisinicline use SEATTLE and VANCOUVER, British Columbia, March 04, 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 new data showing that 6 and 12 weeks of cytisinicline delivers meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts. Achieve also announces late-breaking survey data from ORCA-OL, demonstrating participant experience with extended cytisinicline use.