Achieve Life Sciences NASDAQ: ACHV held its 2026 Annual Meeting of Stockholders virtually, with Chief Executive Officer Andrew Goldberg serving as chairperson of the meeting. Goldberg called the meeting to order and said Erik Atkisson, the company's Chief Legal Officer, would act as secretary and record the minutes.

marketbeat.com - 2026-07-09 20:03:12

The last months were eventful for Achieve Life Sciences, sending the stock strongly down, but later to a new high for the year, implying optimism about the future path. Achieve is, in my view, a more derisked case now, thanks to successful financing, progress on shifting its supply chain, and new leadership. Despite the CRL, ACHV continues to advance. The denial was not drug-related, pointing towards a possible successful outcome in this story.

seekingalpha.com - 2026-07-07 11:33:38

SEATTLE and VANCOUVER, British Columbia, June 29, 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 it has been added to the Russell 2000® Index, effective June 26, 2026, as part of the Russell U.S. Indexes reconstitution. The Company is also a member of the Russell 3000® Index.

globenewswire.com - 2026-06-29 08:30:00

Achieve Life Sciences remains a cytisinicline story, with very positive smoking-cessation data. This also gives cytisinicline some added optionality for vaping. The FDA's CRL appears to be mostly about manufacturing and labeling issues. However, it's not about a particular cytisinicline efficacy or safety problem. ACHV is currently targeting Q4 2026 resubmission and, assuming everything goes according to plan, it could receive approval by 1H2027.

seekingalpha.com - 2026-06-23 07:30:14

Achieve Life Sciences Inc. (NASDAQ:ACHV) on Monday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application seeking approval of cytisinicline, its investigational treatment for nicotine dependence.

benzinga.com - 2026-06-22 11:44:44

The U.S. Food and Drug Administration ​has declined to approve Achieve Life ‌Sciences' drug to treat nicotine dependence in adults, the company said on Monday.

reuters.com - 2026-06-22 08:54:18

CRL Cites Deficiencies at Third-Party Manufacturing Facility No Efficacy or Clinical Safety Deficiencies Identified SEATTLE and VANCOUVER, British Columbia, June 22, 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 that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA's action date.

globenewswire.com - 2026-06-22 08:30:00

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

globenewswire.com - 2026-06-02 08:30:00

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.

globenewswire.com - 2026-05-19 14:15:00

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.

globenewswire.com - 2026-05-19 14:15:00

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.

seekingalpha.com - 2026-05-13 15:17:34

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

seekingalpha.com - 2026-05-12 11:40:47

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.

marketbeat.com - 2026-05-12 10:10:55

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

globenewswire.com - 2026-05-12 07:05:00

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.

globenewswire.com - 2026-05-12 07:00:00

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.

globenewswire.com - 2026-05-05 08:30:00

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

defenseworld.net - 2026-04-24 04:22:58

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.

globenewswire.com - 2026-04-16 08:57:00

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

globenewswire.com - 2026-04-16 08:53:00

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.

globenewswire.com - 2026-04-15 08:00:00