Achieve Life Sciences, Inc.

Nearly one in three adults who were still smoking or vaping after a prior ORCA trial had quit at the end of a year of cytisinicline treatment, with quit rates rising through the year Among the participants new to cytisinicline (prior attempt on placebo), 39% had quit at the end of the year Participants were in their mid-fifties on average, ranging up to age 79, and many had a history of chronic conditions; the typical participant who smoked had made five quit attempts before ORCA-OL, and every participant chose to try again SEATTLE and VANCOUVER, British Columbia, Oct. 21, 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 for nicotine dependence, today announced positive 52-week efficacy results from its long-term, open-label ORCA-OL clinical trial evaluating cytisinicline for cigarette smoking and e-cigarette cessation. The findings were presented at the CHEST 2026 Annual Meeting in Phoenix, Arizona.

SEATTLE and VANCOUVER, British Columbia, Oct. 07, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve and the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced the appointment of Kaitlyn (Kait) Tuson as Senior Vice President, Marketing and Communications. Tuson joins Achieve's executive team and will lead its marketing, brand strategy, and corporate communications as the Company prepares for the potential commercialization of cytisinicline.

SEATTLE and VANCOUVER, British Columbia, Oct. 06, 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 for nicotine dependence, today announced that its board of directors approved stock option grants to purchase an aggregate of 46,500 shares of its common stock and restricted stock unit (“RSU”) awards covering an aggregate of 44,500 shares of its common stock for four new employees. Achieve also announced that the board of directors approved an inducement award grant to Benjamin Halladay, the Company's newly appointed Chief Financial Officer, consisting of an option to purchase up to 200,000 shares of common stock and 200,000 RSUs.

Achieve Life Sciences, Inc. (NASDAQ: ACHV - Get Free Report)'s stock price gapped up before the market opened on Wednesday. The stock had previously closed at $7.69, but opened at $8.08. Achieve Life Sciences shares last traded at $8.0310, with a volume of 186,199 shares traded. Analysts Set New Price Targets Several analysts have recently weighed

Brings public company CFO experience across commercial pharma and business development as Achieve prepares for potential commercialization of cytisinicline Brings public company CFO experience across commercial pharma and business development as Achieve prepares for potential commercialization of cytisinicline

SEATTLE and VANCOUVER, British Columbia, Sept. 28, 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 for nicotine dependence, today announced that new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented at CHEST 2026, held October 18-21 in Phoenix, Arizona.

Achieve Life Sciences is rated a 'buy' as it nears a second NDA resubmission after resolving prior manufacturing issues. ACHV's FDA setback was manufacturing-related, not efficacy or safety, with two successful Phase 3 trials and over 1,500 exposures supporting its profile. ACHV is well-capitalized, holding $188 million in cash post-private placement, sufficient to fund the NDA resubmission and initial launch activities.

Achieve Life Sciences is navigating a manufacturing reset for cytisinicline following a Complete Response Letter citing facility compliance, not efficacy or safety concerns. I remain bullish on ACHV, contingent on resolving manufacturing issues and leveraging a funded transition to commercialization, not market expansion or first-line displacement. ACHV's cash runway, bolstered by $180M upfront financing, appears sufficient through potential FDA approval in 1H 2027, but dilution and arbitration risks must be monitored.