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 (ACHV) granted new hire inducement equity awards under its 2024 Equity Inducement Plan to 7 employees, consisting of stock options for 315,000 shares and RSUs covering 283,000 shares of common stock.
The stock options have an exercise price equal to the closing price on the grant date, a four-year term, and vest 25% after one year with the remaining 75% in 36 monthly installments, subject to continued service. RSUs vest over four years in 25% annual increments, also subject to continued service. The grants were approved by the board and made as inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4). The company continues to focus on cytisinicline, supported by completed Phase 3 and Phase 2 studies for smoking and e-cigarette cessation.
Achieve Life Sciences (Nasdaq: ACHV) reported second quarter 2026 results and business updates, highlighted by closing a private placement of up to $354 million, including $180 million upfront and up to $174 million from milestone-based warrants exercisable around potential FDA approval of cytisinicline.
According to Achieve, the FDA issued a Complete Response Letter on June 20, 2026, limited to cGMP issues at a prior third-party facility and unfinished labeling, with no identified deficiencies in cytisinicline’s clinical efficacy or safety. The company is transitioning finished drug product manufacturing to Adare Pharma Solutions, has completed technology transfer and an initial engineering batch, and intends to resubmit its NDA in Q4 2026, anticipating potential FDA approval in the first half of 2027.
Achieve strengthened its leadership with a new CEO, multiple senior commercial, CMC, and quality hires, and six new directors. ORCA-OL 52‑week safety data in 475 participants showed no new safety signals, and analyses in participants with cancer history from ORCA-2/3 showed cytisinicline was well tolerated with numerically higher abstinence than placebo. Cash, cash equivalents, and marketable securities were $187.3 million at June 30, 2026; Q2 operating expenses were $18.4 million and net loss was $74.8 million, including a non‑cash $48.7 million warrant revaluation charge.
Achieve Life Sciences (Nasdaq: ACHV) appointed Ronald Dadino as Senior Vice President, Chemistry, Manufacturing and Controls (CMC) and Supply Chain, and Gloria Cosgrove as Senior Vice President, Quality. Both are U.S.-based veterans in pharmaceutical manufacturing, supply chain, and quality, joining as Achieve advances cytisinicline toward NDA resubmission and a potential U.S. commercial launch.
Dadino will oversee CMC, technical operations, and the end-to-end cytisinicline supply chain, while Cosgrove will lead quality across manufacturing, clinical, and regulatory areas, including smoking and vaping cessation programs. Craig Donnelly stepped down as Chief Operations Officer effective July 31, 2026, with his responsibilities transitioned to the new leaders.
Achieve Life Sciences (Nasdaq: ACHV) announced that its board approved new-hire equity inducement awards under the 2024 Equity Inducement Plan for six employees, consisting of stock options to purchase an aggregate 1,190,000 shares and RSU awards covering 125,000 shares of common stock. The stock options have an exercise price equal to the closing price on the grant date, a four-year term, and vest 25% after one year with the remaining 75% vesting in 36 equal monthly installments, subject to continued service. The RSUs vest over four years in 25% annual increments from commencement of employment. According to Achieve, the awards are intended as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and support its late-stage development of cytisinicline for nicotine dependence.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence, has been added to the Russell 2000 Index, effective June 26, 2026, as part of the Russell U.S. Indexes reconstitution. Achieve is also a member of the Russell 3000 Index, widely used by institutional investors and index-tracking funds.
Achieve Life Sciences (Nasdaq: ACHV) received a Complete Response Letter from the FDA for its cytisinicline NDA. The CRL cites manufacturing-related deficiencies at a prior third-party facility and incomplete product labeling, with no clinical efficacy or safety deficiencies identified.
Achieve has transitioned commercial manufacturing to Adare Pharma Solutions, completed technology transfer, produced an engineering batch, and qualified testing at Adare’s site. The company plans to resubmit the NDA in Q4 2026, targeting potential FDA approval in H1 2027 and subsequent US launch, supported by two Phase 3 trials and long-term safety data in more than 1,500 participants.
Achieve Life Sciences (Nasdaq: ACHV) appointed Jeffrey Farrow and Reid Waldman, MD to its Board of Directors as it advances toward potential cytisinicline NDA resubmission, approval and launch.
Farrow is CFO and Chief Strategy Officer at Tarsus; Waldman is Founder and CEO of Veradermics (NYSE: MANE).
Achieve Life Sciences (Nasdaq: ACHV) presented final long-term safety data from the 52-week ORCA-OL cytisinicline trial in adults with nicotine dependence, completing the clinical evidence package supporting its smoking cessation NDA.
The 475-participant study showed no new safety signals, low nausea incidence (2.5%), and 5.7% discontinuations due to treatment-related adverse events.
Achieve Life Sciences (Nasdaq: ACHV) announced three senior leadership appointments, reinforcing its move toward commercializing cytisinicline for nicotine dependence. Christopher Martin joins the Board, while Mark Zappia becomes Senior Vice President, Commercial, and Jim Willis becomes Vice President of Sales and Sales Enablement.
The trio previously led the U.S. launch of Ohtuvayre (ensifentrine) at Verona Pharma, later acquired by Merck for $10.8 billion. The appointments follow CEO Andrew Goldberg’s April 2026 hiring and a recent financing of up to $354 million ($180 million upfront plus up to $174 million in milestone warrants). Tom King will leave the Board in June 2026, with Lucian Iancovici becoming Chairman.
Achieve Life Sciences (Nasdaq: ACHV) reported Q1 2026 results and major corporate updates, including a private placement of up to $354 million ($180 million upfront and up to $174 million in milestone-based warrants).
Achieve named Adare Pharma Solutions as primary U.S. manufacturing partner, expects an FDA Complete Response Letter by June 20, 2026, plans NDA resubmission in Q4 2026, and targets a U.S. cytisinicline launch in H1 2027. Q1 operating expenses were $10.5 million with a net loss of $10.2 million and cash of $29.3 million, excluding roughly $168.6 million in estimated net private placement proceeds.