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Achieve Life Sciences, Inc.
ACHVHealthcareNASDAQCA
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Appointments Add Deep Biopharmaceutical Commercial Strategy, Clinical and Finance Expertise as Company Advances Toward Potential Cytisinicline Approval and Launch Appointments Add Deep Biopharmaceutical Commercial Strategy, Clinical and Finance Expertise as Company Advances Toward Potential Cytisinicline Approval and Launch
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.
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.
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 Life Sciences, Inc. (NASDAQ: ACHV - Get Free Report) has been assigned an average recommendation of "Buy" from the six ratings firms that are presently covering the firm, Marketbeat reports. One investment analyst has rated the stock with a sell rating, three have assigned a buy rating and two have issued a strong buy rating
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.
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.
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.
Achieve Life Sciences, Inc. (NASDAQ: ACHV - Get Free Report) shares passed above its 200-day moving average during trading on Thursday. The stock has a 200-day moving average of $4.24 and traded as high as $4.37. Achieve Life Sciences shares last traded at $4.14, with a volume of 530,131 shares changing hands. Analyst Ratings Changes
