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 specialty pharmaceutical company dedicated to addressing the global nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid intended for smoking and e-cigarette cessation. The company's main focus is advancing cytisinicline as a viable treatment option to help individuals overcome nicotine dependence, a significant public health concern affecting millions worldwide.
Headquartered in Seattle, Washington, and Vancouver, British Columbia, Achieve Life Sciences has made notable strides in its clinical development programs. The company has successfully completed two Phase 3 trials (ORCA-2 and ORCA-3) and a Phase 2 trial (ORCA-V1) for e-cigarette cessation. Cytisinicline has demonstrated a strong safety profile and statistical significance in increasing the likelihood of quitting nicotine compared to placebo.
In February 2024, Achieve announced a substantial $124.2 million financing, enabling the company to further its clinical development, particularly the long-term exposure trial (ORCA-OL), which is critical for its New Drug Application (NDA) submission anticipated in the first half of 2025. This financing also involves participation from strategic investors such as Propel Bio Partners LLC, Nantahala Capital, and Sopharma, among others.
The company recently announced positive outcomes from its Phase 2 ORCA-V1 trial, where cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo. These results were published in the Journal of the American Medical Association (JAMA) Internal Medicine, further cementing cytisinicline's potential as a breakthrough treatment in nicotine cessation.
Achieve Life Sciences collaborates with key industry stakeholders and regulatory bodies like the U.S. Food and Drug Administration (FDA) to ensure the comprehensive evaluation of cytisinicline's efficacy and safety. The company is on track to begin the ORCA-OL trial in the second quarter of 2024, with results expected to support its NDA submission and potential FDA approval by 2025.
As of March 31, 2024, the company reported cash and cash equivalents totaling $66.4 million, reflecting its strong financial position post the recent equity financing. Achieve Life Sciences remains committed to its mission of providing effective treatment solutions for nicotine addiction and improving public health outcomes globally.
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.
Achieve Life Sciences (Nasdaq: ACHV) announced its completion of the last study follow-up visit for the Phase 3 ORCA-3 trial, aimed at evaluating the efficacy of cytisinicline for smoking cessation. The trial involved 792 subjects and is pivotal for gaining FDA approval as the first non-nicotine prescription treatment for smoking cessation in nearly 20 years. Topline data is expected in Q2 2023, which will reveal the primary endpoint of biochemically verified continuous abstinence. CEO John Bencich emphasized the significance of these results, correlating them with potential market impact and future commercialization.
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