Achieve Life Sciences Inc - ACHV STOCK NEWS

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.

Achieve Life Sciences (Nasdaq: ACHV) announced an inducement grant of stock options for a new employee on March 14, 2023. The Board approved the grant of 25,000 stock options as part of an employment agreement, aligning with Nasdaq Listing Rule 5635(c)(4). The stock options vest over four years, with the first 25% vesting after one year, and the remainder vesting monthly. Cytisinicline, Achieve's primary focus, aims to combat nicotine addiction, a significant global health issue, with no FDA-approved treatments for e-cigarette cessation currently available.

Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced its fourth quarter and year-end 2022 financial results on March 16, 2023. The company reported a net loss of $11.2 million for Q4 and $42.4 million for the year. Achieve achieved key milestones in its cytisinicline development, including completing dosing in the Phase 2 ORCA-V1 trial and final subject dosing in the Phase 3 ORCA-3 trial, both targeting smoking cessation. The company secured $18.9 million through a private placement to fund ongoing research. A recent patent for a new cytisinicline formulation was granted by the USPTO. The company expects topline results from ongoing trials in Q2 2023.

Achieve Life Sciences (NASDAQ: ACHV) announced the completion of the last follow-up visit for subjects in the Phase 2 ORCA-V1 trial evaluating the efficacy and safety of cytisinicline for nicotine e-cigarette cessation. Conducted across 5 locations in the U.S. with 160 participants, the trial compares cytisinicline to a placebo over 12 weeks. Topline results are expected in 2Q 2023. The trial is backed by the National Institute on Drug Abuse. The primary endpoint is continuous abstinence in the last month of treatment.

Achieve Life Sciences (NASDAQ: ACHV) announced data from the Phase 3 ORCA-2 trial for cytisinicline, aimed at smoking cessation, presented at the SRNT Annual Meeting in San Antonio, TX. The trial showed a 6-8 times higher likelihood of smoking abstinence in participants taking 3mg cytisinicline three times daily over 6-12 weeks compared to placebo. Notably, successful abstinence was observed across various demographics. With 82% treatment compliance and no serious adverse events recorded, Achieve is optimistic about future FDA approval as it also prepares for forthcoming ORCA-3 and ORCA-V1 trial results expected in Q2 2023.