Achieve Life Sciences

ACHV

Market cap $538M

ORCA-OL data complete the clinical evidence package supporting the cytisinicline smoking cessation NDA No new safety signals identified by the independent Data Safety Monitoring Committee over 52 weeks of continuous exposure Nausea — a common barrier to treatment adherence with smoking cessation therapies — was reported in only 2.5% of participants over 52 weeks of continuous exposure¹ SEATTLE and VANCOUVER, British Columbia, May 19, 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 the presentation of comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting. Additional cytisinicline data will be presented at ATS on May 20.

Achieve Life Sciences (ACHV) is downgraded to 'Hold' due to anticipated CRL of cytisinicline for smoking cessation and NDA resubmission in Q4 2026. FDA inspection issues at a third-party manufacturer will trigger a Complete Response Letter on or before June 20,2026, pushing NDA resubmission to Q4 2026 and potential launch H1 2027. Company has shifted cytisinicline supply to Adare, but future FDA inspections at Adare's facility remain a key risk for approval timelines.

Achieve Life Sciences, Inc. (ACHV) Q1 2026 Earnings Call Transcript

Achieve Life Sciences NASDAQ: ACHV used its first-quarter 2026 earnings call to outline a transition period marked by new leadership, a major financing, manufacturing changes tied to its cytisinicline regulatory timeline and preparations for a potential commercial launch in 2027.

Christopher Martin joins the Board of Directors, with Mark Zappia and Jim Willis joining as Senior Vice President of Commercial and Vice President of Sales, reuniting the team behind the launch of Ohtuvayre®, one of the most successful specialty pharmaceutical launches in recent industry history Christopher Martin joins the Board of Directors, with Mark Zappia and Jim Willis joining as Senior Vice President of Commercial and Vice President of Sales, reuniting the team behind the launch of Ohtuvayre®, one of the most successful specialty pharmaceutical launches in recent industry history

Closed Private Placement of Up to $354 Million, Including $180 Million Upfront and $174 Million in Milestone-Driven Warrants Appoints New CEO and Expands Board of Directors Advances U . S . -based Manufacturing Transition & Partnership Conference Call Scheduled for 8:30 AM EDT Today, May 12, 2026 SEATTLE and VANCOUVER, British Columbia, May 12, 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 financial results for the first quarter of 2026 and provided corporate highlights, including the recent financing and leadership updates.

SEATTLE and VANCOUVER, British Columbia, May 05, 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 first quarter 2026 financial results and provide a corporate update on Tuesday, May 12, 2026, at 8:30 AM EDT.

Achieve Names Two New Exemplary Healthcare Leaders to its Board of Directors  New Leadership and Financing, up to $354 Million ($180 Million Upfront and $174 Million Dependent on the Exercise of Milestone Warrants), Strengthen Achieve's Position to Execute Development and Launch of Cytisinicline, if Approved, as the First New Treatment for Nicotine Dependence in Two Decades SEATTLE and VANCOUVER, British Columbia, April 16, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV) today announced it has appointed Andrew D. Goldberg, MD, as Chief Executive Officer and as a member of the Board of Directors, effective following the closing of Achieve's recently announced financing.

$180 Million Financing Upfront with Up to an Additional $174 Million from Warrants Exercisable Within 20 Days of FDA Approval

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.