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.
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Achieve Life Sciences (NASDAQ: ACHV) will report its Q1 2023 financial results on May 9, 2023, at 4:30 PM EDT, along with updates on its cytisinicline development program. Cytisinicline is an investigational treatment aimed at assisting with smoking cessation and nicotine dependence. Tobacco-related deaths exceed 8 million globally, with various diseases linked to smoking. Achieve emphasizes the urgency of addressing nicotine addiction, especially as e-cigarette usage rises among adults and adolescents. The company aims to develop cytisinicline as an effective treatment for nicotine addiction. The press release also contains forward-looking statements regarding clinical development and market potential, acknowledging risks such as regulatory approval and funding challenges.
Achieve Life Sciences (Nasdaq: ACHV) has announced positive topline results from its Phase 2 ORCA-V1 trial, which studied the efficacy of cytisinicline for e-cigarette cessation among 160 adult daily e-cigarette users. The study revealed that participants receiving 12 weeks of cytisinicline had 2.6 times higher odds of quitting vaping compared to the placebo group. The vaping cessation rate was 31.8% for cytisinicline users versus 15.1% for those on placebo. Cytisinicline was well tolerated, with no serious adverse events reported. This trial marks the first randomized, placebo-controlled study demonstrating the efficacy of cytisinicline for e-cigarette cessation. Achieve is also set to release results from the Phase 3 ORCA-3 trial in Q2 2023, targeting cigarette smoking cessation. The study is supported by the National Institute on Drug Abuse.
Achieve Life Sciences, a late-stage pharmaceutical company, announced that CEO John Bencich will present at the Life Science Innovation Northwest 2023 Conference on April 25-26 in Seattle. The presentation is scheduled for April 25 at 10:50 A.M. PDT in the Biotechnology Session. Achieve focuses on developing cytisinicline for smoking cessation and nicotine dependence, addressing a critical health issue responsible for over eight million deaths annually worldwide.
Cytisinicline, a plant-based alkaloid, could help treat nicotine addiction by interacting with brain receptors, easing withdrawal symptoms and reducing nicotine satisfaction. Currently, it is investigational and not FDA-approved for use in the U.S. For more details, visit Achieve's website.
Achieve Life Sciences (Nasdaq: ACHV) announced the appointment of three new board members: Stuart Duty, Thomas King, and Tom Sellig, as part of a strategy to steer the company towards success with cytisinicline, a treatment for smoking cessation. These appointments follow a Cooperation Agreement with shareholders and will be voted on at the Annual Meeting in June 2023. The company thanked outgoing board members Donald Joseph, Martin Mattingly, and Jay Moyes for their contributions. The new members bring extensive experience in finance and biopharmaceuticals, which is expected to aid in advancing cytisinicline through FDA approval.