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, Inc. (Nasdaq: ACHV) is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. The ACHV news feed highlights company announcements related to its cytisinicline program for smoking cessation in adults and for nicotine e-cigarette or vaping cessation.
News items from Achieve commonly cover clinical and regulatory milestones for cytisinicline, including the acceptance of its New Drug Application by the U.S. Food and Drug Administration (FDA) for smoking cessation, assignment of a Prescription Drug User Fee Act (PDUFA) target action date, and progress in long-term safety trials such as ORCA-OL. Releases also describe Phase 3 efficacy data from ORCA-2 and ORCA-3, Phase 2 results in vaping cessation (ORCA-V1), and post hoc analyses in specific populations such as individuals with chronic obstructive pulmonary disease (COPD).
Investors and observers can use the ACHV news page to follow regulatory designations and programs cited by the company, including Breakthrough Therapy designation for nicotine e-cigarette or vaping cessation and the Commissioner’s National Priority Voucher awarded for cytisinicline. Additional news topics include executive appointments, equity inducement awards, financing transactions disclosed in conjunction with SEC filings, and scheduling of earnings calls and investor meetings.
This page provides a centralized view of Achieve’s press releases and related updates, offering context on how the company describes its progress in advancing cytisinicline as an investigational treatment of nicotine dependence. For those tracking ACHV stock or the development of cytisinicline, the news feed can be revisited regularly to see new clinical, regulatory, and corporate disclosures as they are issued by the company.
Achieve Life Sciences (NASDAQ:ACHV) announced the publication of new data in Thorax demonstrating cytisinicline's effectiveness for smoking cessation in patients with chronic obstructive pulmonary disease (COPD). The post hoc analysis of two Phase 3 trials (ORCA-2 and ORCA-3) showed that cytisinicline significantly improved quit rates compared to placebo in both COPD and non-COPD participants.
The study revealed statistically significant increases in continuous smoking abstinence with cytisinicline versus placebo, demonstrating comparable quit rates between COPD and non-COPD groups despite COPD patients having more severe tobacco use histories. The treatment showed a favorable safety profile with no serious treatment-related adverse events.
The FDA has accepted Achieve's New Drug Application for cytisinicline with a PDUFA target date of June 20, 2026. This development is particularly significant as nearly 6 million COPD patients in the U.S. currently smoke, with smoking attributed to 80% of COPD deaths.
Achieve Life Sciences (NASDAQ:ACHV) has promoted Craig Donnelly to Chief Operations Officer. Donnelly, who joined Achieve in 2022 as Executive Vice President of Chemistry, Manufacturing, and Controls (CMC) and Regulatory CMC, brings over 25 years of biopharmaceutical expertise.
In his new role, Donnelly will lead the integration of supply chain and manufacturing activities with commercial strategy as the company prepares for the anticipated launch of cytisinicline in mid-late 2026. The drug candidate represents the first potential smoking cessation treatment approval in nearly two decades.
Prior to Achieve, Donnelly held senior positions at NuCana, ICON, F. Hoffman-La Roche, and began his career at Pfizer. He holds a Bachelor's with Honors in Chemical and Pharmaceutical Sciences from the University of Sunderland.
Achieve Life Sciences (NASDAQ:ACHV) has appointed Dr. Mark Rubinstein as Interim Chief Medical Officer, succeeding Dr. Cindy Jacobs. Dr. Rubinstein, who joined Achieve as Head of Medical Affairs in October 2024, brings extensive experience in clinical development and medical affairs from his roles at Blip and Juul Labs.
The transition comes at a crucial time as the company recently received FDA acceptance of its cytisinicline New Drug Application for nicotine dependence treatment. Dr. Rubinstein, a Yale Medical School graduate and Professor Emeritus at UCSF, will lead the company's efforts to address nicotine dependence among the estimated 15 million American adults who attempt to quit smoking annually.
Achieve Life Sciences (NASDAQ:ACHV) announced the FDA's acceptance of its New Drug Application (NDA) for cytisinicline, a novel smoking cessation treatment. The FDA has set a PDUFA target date of June 20, 2026, marking a significant milestone in potentially introducing the first new FDA-approved smoking cessation pharmacotherapy in two decades.
The NDA is supported by comprehensive data from the ORCA-2 and ORCA-3 Phase 3 trials, involving over 2,000 participants. The trials demonstrated significantly higher smoking abstinence rates with cytisinicline compared to placebo, both at the end of treatment and through week 24. Safety data includes over 400 participants with six-month exposure and 200 with one-year exposure, showing no new safety concerns.
Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, has announced its participation in two upcoming investor conferences in New York. CEO Rick Stewart will present at the H.C. Wainwright Global Investment Conference on September 8, 2025, participating in a fireside chat at 11:00 AM ET. Additionally, the company will attend the Lake Street Best Ideas Growth Conference (BIG9) on September 11, 2025, for one-on-one meetings with investors.
Achieve Life Sciences (NASDAQ: ACHV) reported significant Q2 2025 milestones, including the submission of a New Drug Application (NDA) to the FDA for cytisinicline, their smoking cessation treatment. The company secured a strategic partnership with Omnicom for commercialization and raised $49.3 million through a public offering.
Key achievements include meeting FDA long-term exposure requirements in the ORCA-OL trial and publication of Phase 3 ORCA-3 results in JAMA Internal Medicine. The company reported $55.4 million in cash and equivalents as of June 30, with a net loss of $12.7 million for Q2 2025.
Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, announced its participation in the BTIG Virtual Biotechnology Conference on July 29-30, 2025. CEO Rick Stewart will engage in a fireside chat with BTIG Biotechnology Analyst Julian Harrison on July 29 at 3:20 pm EDT.
The company focuses on developing treatments for nicotine dependence through its cytisinicline program. Interested parties can register for the conference by contacting BTIG directly.
Achieve Life Sciences (NASDAQ:ACHV), a late-stage specialty pharmaceutical company, will release its second quarter 2025 financial results on Thursday, August 7, 2025, at 8:30 AM EDT. The company, which focuses on developing cytisinicline for nicotine dependence and smoking cessation, will also provide updates on their development program during the call.
Investors can access the webcast through the company's website or join via phone by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) with conference ID 13754433. A replay will be available approximately three hours after the call and remain archived for 90 days.
Achieve Life Sciences (NASDAQ: ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, has announced the closing of its public offering. The company successfully raised $45.0 million in gross proceeds through the offering of 15,000,000 shares of common stock and warrants to purchase up to 16,766,666 shares at $3.00 per share and accompanying warrant.
The offering includes warrants to purchase up to 1,766,666 additional shares issued following the underwriters' partial exercise of their option. The proceeds will be used to fund cytisinicline's advancement through potential FDA marketing approval and for working capital purposes. Citizens Capital Markets and Raymond James served as joint book-running managers, with Lake Street Capital Markets acting as financial advisor.
Achieve Life Sciences (NASDAQ:ACHV) has announced the pricing of an underwritten public offering of 15 million shares of common stock and accompanying warrants at $3.00 per share, aiming to raise approximately $45.0 million in gross proceeds.
The offering includes common warrants to purchase up to 15 million additional shares, exercisable at $3.00 per share or for pre-funded warrants at $2.999, valid for five years. Underwriters have a 30-day option to purchase up to 2.25 million additional shares and/or warrants. The company plans to use the proceeds to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital purposes.