Achieve Life Sciences Inc. ACHV is moving closer to a pivotal moment as it seeks FDA approval for cytisinicline, a potential first new smoking cessation therapy in nearly two decades, positioning the company for a high-stakes commercial launch in 2026.

Achieve (ACHV) Q2 Net Loss Hits $12.7M

SEATTLE and VANCOUVER, British Columbia, Aug. 07, 2025 (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 for smoking cessation, today announced its financial results for second quarter 2025. “This quarter represents a significant step forward for Achieve.

SEATTLE and VANCOUVER, British Columbia, July 29, 2025 (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 for smoking cessation, today announced that the company will participate in the BTIG Virtual Biotechnology Conference being held July 29-30, 2025.

SEATTLE and VANCOUVER, British Columbia, July 24, 2025 (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 for smoking cessation, today announced it will report its second quarter 2025 financial results and provide a corporate update on the cytisinicline development program on Thursday, August 7, 2025, at 8:30 AM EDT. To access the webcast, please use the following link: 2Q25 Earnings Webcast.

ACHV's cytisinicline shows best-in-class efficacy and safety for smoking cessation, supported by strong clinical data and recent NDA submission. The target market is large, with millions seeking smoking cessation annually. Recent financing extends ACHV's cash runway through FDA approval, but further capital will be needed for commercialization.

SEATTLE and VANCOUVER, British Columbia, June 30, 2025 (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 for smoking cessation, today announced the closing of its underwritten public offering of 15,000,000 shares of its common stock and accompanying common warrants to purchase up to 16,766,666 shares of common stock at a public offering price of $3.00 per share and accompanying warrant, which includes common warrants to purchase up to 1,766,666 shares issued upon the partial exercise by the underwriters of their option to purchase additional shares of common stock and/or accompanying warrants. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $45.0 million.

SEATTLE and VANCOUVER, British Columbia, June 26, 2025 (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 for smoking cessation, today announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock and accompanying common warrants to purchase up to 15,000,000 shares of common stock. The shares of common stock and accompanying common warrants were offered collectively at a price to the public of $3.00 per share and accompanying common warrant. Achieve has also granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock and/or accompanying common warrants to purchase up to an additional 2,250,000 shares of common stock (or pre-funded warrants in lieu thereof) in connection with the public offering.

Achieve Life Sciences (ACHV) is positioned for growth with its lead smoking cessation therapy, cytisinicline, advancing through late-stage clinical trials. The company addresses a significant unmet need in tobacco addiction, with cytisinicline showing promising efficacy and safety data compared to existing therapies. While FDA approval may be difficult, the low valuation and high potential peak sales provide a decent risk/reward profile.

Reiterates Planned Submission of an NDA for Cytisinicline to FDA in June 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, May 13, 2025 SEATTLE and VANCOUVER, British Columbia, May 13, 2025 (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 for smoking cessation, today announced its financial results for first quarter 2025 and confirmed that it plans to submit the upcoming New Drug Application (NDA) for cytisinicline to the U.S. Food and Drug Administration (FDA) in June 2025. “The Achieve team is fully committed to finalizing the NDA for submission to the FDA next month.