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 (NASDAQ: ACHV) generates news driven by its position as a clinical-stage pharmaceutical company developing cytisine for smoking cessation. As a single-asset biotech pursuing FDA approval, the company's news flow centers on regulatory milestones, clinical trial developments, and corporate financing activities that directly impact its path to commercialization.
The company's news typically includes FDA interactions and regulatory submissions, clinical trial results and study updates, patent grants protecting its intellectual property, executive appointments and leadership changes, and quarterly financial reports detailing cash runway and operational progress. Each regulatory milestone or setback carries significant weight for investors monitoring ACHV's development timeline.
Achieve Life Sciences' focus on nicotine addiction treatment places its news within the broader context of public health initiatives and smoking cessation research. News items often reference the company's clinical data, its engagement with the FDA, and strategic decisions regarding partnerships or capital allocation. The specialty pharmaceutical sector generates distinct news patterns compared to diversified healthcare companies, with material announcements typically tied to specific development catalysts rather than quarterly revenue fluctuations.
Bookmark this page to follow ACHV's regulatory progress, clinical announcements, and corporate developments as the company advances cytisine toward potential FDA approval and commercial launch.
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.
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