Welcome to our dedicated page for Achieve Life Sciences news (Ticker: ACHV), a resource for investors and traders seeking the latest updates and insights on Achieve Life Sciences stock.
Achieve Life Sciences reports company news around the development and potential commercialization of cytisinicline, an investigational treatment for nicotine dependence. Cytisinicline is a plant-based alkaloid that binds to nicotinic acetylcholine receptors and is being studied for smoking cessation and e-cigarette cessation; it has not been approved by the FDA for any indication in the United States.
Recurring ACHV updates include financial results, clinical data presentations, regulatory and manufacturing progress, supply-chain arrangements for cytisinicline, capital-structure actions, and governance changes. Company announcements also cover scientific publications, board and executive appointments, and operational steps tied to preparing the cytisinicline program for potential commercial use if regulatory approval is obtained.
Achieve Life Sciences (Nasdaq: ACHV) will report first quarter 2026 financial results and provide a corporate update on May 12, 2026 at 8:30 AM EDT. A live webcast and conference call will be available, with a replay posted about three hours after the call and archived for 90 days.
Dial-in numbers and a conference ID are provided for live participation.
Achieve Life Sciences (NASDAQ: ACHV) appointed Andrew D. Goldberg, MD as CEO and added two experienced life‑science investors to its board, effective upon closing of a announced financing. The company said the financing provides up to $354 million ($180M upfront; $174M tied to milestone warrants) to advance cytisinicline toward potential FDA approval as a first new nicotine‑dependence treatment in two decades.
Outgoing CEO Richard Stewart will remain on the board to support the transition and commercialization efforts.
Achieve Life Sciences (Nasdaq: ACHV) announced a private placement to raise up to $354 million, including approximately $180 million upfront and up to an additional $174 million via milestone-driven warrants.
The financing includes sale of 49,418,069 shares at $3.635 per share (or pre-funded warrants), accompanying warrants exercisable on FDA approval, and an expected close on April 17, 2026. The company said proceeds will fund a Phase 3 e-cigarette cessation trial, commercialization of cytisinicline, and general corporate purposes. Andrew D. Goldberg, MD was appointed CEO effective after closing.
Achieve Life Sciences (Nasdaq: ACHV) completed analytical method transfer and produced its first cytisinicline engineering batch at U.S.-based Adare Pharma Solutions in Vandalia, Ohio, providing domestic manufacturing capability and supply‑chain redundancy.
The company expects an FDA Complete Response Letter by June 20, 2026, plans an NDA resubmission naming Adare in Q4 2026, and reiterates a potential commercial launch in the first half of 2027.
Achieve Life Sciences (Nasdaq: ACHV) reported a Nicotine & Tobacco Research publication linking cytisinicline’s receptor selectivity to favorable tolerability. Key preclinical findings: 99% displacement at the α4β2 nicotinic receptor and -8% displacement at the 5-HT3 serotonin receptor. The paper and one‑year open‑label safety data together support a biological explanation for low nausea rates seen in clinical studies.
Achieve Life Sciences (Nasdaq: ACHV) reported 4Q and full‑year 2025 results and development updates for cytisinicline. Key regulatory progress includes FDA acceptance of the NDA with a PDUFA date of June 20, 2026. The company completed the 334‑participant ORCA‑OL yearlong safety study and announced a U.S. manufacturing partnership with Adare Pharma Solutions to support a planned U.S. commercial launch in H1 2027.
As of December 31, 2025, cash and marketable securities were $36.4M; 2025 net loss was $54.7M with operating expenses of $54.9M. Conference call held March 24, 2026.
Achieve Life Sciences (Nasdaq: ACHV) will report fourth quarter and full year 2025 financial results and provide a corporate update on its cytisinicline development program on March 24, 2026 at 8:30 AM EDT.
Investors can access a live webcast, join the conference call (877-269-7756 U.S. & Canada; 201-689-7817 International; conference ID 13758715), and view a replay posted about three hours after the call that will be archived for 90 days.
Achieve Life Sciences (Nasdaq: ACHV) reported pooled Phase 3 findings showing meaningful quitting success with cytisinicline in 1,602 people who smoke, including those with prior exposure to varenicline, bupropion, and NRT.
Late-breaking ORCA-OL survey data describe participant experience with extended cytisinicline use up to one year. Presentations occur at SRNT 2026 (March 4–7) in Baltimore.
Achieve Life Sciences (Nasdaq: ACHV) announced that on January 28, 2026 its board approved stock option grants totaling 115,000 shares for five new employees under the 2024 Equity Inducement Plan. Options have an exercise price equal to the closing price on January 28, 2026, four-year terms, and standard time-based vesting (25% after one year, then 36 monthly installments).
The grants were made as inducements in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the 2024 Equity Inducement Plan and individual stock option agreements.
Achieve Life Sciences (Nasdaq: ACHV) confirmed the promotion of Dr. Mark Rubinstein from Interim Chief Medical Officer to permanent Chief Medical Officer, effective Jan. 12, 2026.
Dr. Rubinstein served as Interim CMO since September 2025 and joined Achieve as Head of Medical Affairs in October 2024. The company said clinical and regulatory milestones were achieved during his interim tenure; he co‑authored a paper in Thorax reporting data on cytisinicline’s potential efficacy and tolerability for smoking cessation in people with COPD. Management highlighted his experience as the company advances toward FDA review for cytisinicline.