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) presented 52-week cytisinicline results showing 31.2% four-week sustained abstinence in its open-label ORCA-OL smoking and vaping cessation trial. The analysis included 475 treated adults who were still smoking or vaping after a counseling-supported quit attempt in a prior ORCA trial.
Overall abstinence rose from 25.5% at Weeks 9–12 to 30.3% at Weeks 21–24. At Weeks 49–52, rates were 39.4% for prior placebo recipients and 27.8% for prior cytisinicline recipients. Rates were 32.8% among exclusive smokers and 24.6% among exclusive vapers. Of 479 enrolled participants, 69.7% completed the 52-week study. Treatment-related adverse events included abnormal dreams (7.8%), insomnia (6.5%) and headache (3.8%); 3.6% discontinued because of treatment-related adverse events. The independent safety monitoring committee identified no new safety signals. Results were presented at CHEST 2026.
Lisata Therapeutics (Nasdaq: LSTA) appointed Jeffrey Farrow to its Board of Directors as a Class III director, effective October 13, 2026. Farrow fills a newly created seat, expanding the Board from seven to eight members, and will serve on the Audit Committee. The Board determined that he is independent under Nasdaq listing rules.
Farrow currently serves as Chief Financial Officer and Chief Strategy Officer of Tarsus Pharmaceuticals, roles he has held since April 2023. He also serves on the boards of Clover Biopharmaceuticals and Achieve Life Sciences.
Achieve Life Sciences (ACHV) appointed Kaitlyn Tuson as Senior Vice President, Marketing and Communications to lead marketing, brand strategy and corporate communications.
Tuson joins the executive team as Achieve prepares for the potential commercialization of cytisinicline, its nicotine-dependence treatment candidate. The company plans to resubmit its New Drug Application, a request for regulatory approval. Tuson brings 15 years of healthcare experience, including go-to-market leadership spanning six pharmaceutical launches, three involving blockbuster therapies. Her work includes campaigns for healthcare providers and consumers across more than 40 therapeutic areas and conditions globally.
The appointment follows a financing of up to $354 million among Achieve’s commercialization-preparation steps in 2026.
Achieve Life Sciences (ACHV) approved equity inducement awards for four new employees and newly appointed Chief Financial Officer Benjamin Halladay.
The four employees received stock option grants covering 46,500 shares and restricted stock units (RSUs) covering 44,500 shares. Halladay’s award comprises an option to purchase up to 200,000 shares and 200,000 RSUs. Options have an exercise price equal to the closing share price on the applicable grant date. Both award types vest over four years, subject to continued service. The grants were made under the 2024 Equity Inducement Plan as inducements to enter employment.
Achieve Life Sciences (Nasdaq: ACHV) appointed Benjamin Halladay as Chief Financial Officer, effective October 5, 2026, succeeding Mark Oki. Halladay will oversee financial strategy, accounting, investor relations, information technology and other administrative functions. Oki will step down on the same date, having served through Achieve’s Phase 3 program and New Drug Application submission.
Halladay served as CFO of Esperion Therapeutics from November 2022 until July 2026 and brings more than 15 years of financial management experience across commercial and launch environments. His earlier roles included work on Lipitor and Chantix at Pfizer and a position at National Oilwell Varco. Achieve said his public-company finance and operating experience fits its preparations for potential commercialization of cytisinicline, its treatment in development for nicotine dependence.
Achieve Life Sciences (ACHV) will present 52-week cytisinicline efficacy data for smoking and vaping cessation at CHEST 2026 on October 20.
The open-label ORCA-OL study enrolled 475 adults from earlier ORCA trials who smoked or vaped daily. Participants received 3 mg of cytisinicline three times daily with behavioral support for 52 weeks. The analysis evaluated biochemically verified four-week sustained abstinence and seven-day point prevalence abstinence. No efficacy results were disclosed.
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.