Achieve Life Sciences Inc Stock Price, News & Analysis

Achieve Life Sciences (Nasdaq: ACHV) reported strong first quarter 2022 results, highlighting significant outcomes from the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation. The trial showed a 32.6% abstinence rate at weeks 9-12 for those on cytisinicline, compared to 7.0% for placebo. The company gained access to an additional $10 million in funding via a revised agreement with Silicon Valley Bank. Achieve ended the quarter with $36.4 million in cash and reported a net loss of $7.6 million on operating expenses of $7.2 million.

Achieve Life Sciences (NASDAQ: ACHV) announced positive topline results from the Phase 3 ORCA-2 trial for cytisinicline, showing significant efficacy in smoking cessation. Participants receiving 12 weeks of treatment demonstrated a 6.3x higher likelihood of quitting smoking compared to placebo, while those receiving 6 weeks showed an 8x increase. Continuous abstinence rates were 21.1% and 8.9% respectively after treatment. The trial highlighted cytisinicline's safety with low adverse event rates. Achieve is seeking FDA approval for this potential breakthrough in smoking cessation therapy.

Achieve Life Sciences (Nasdaq: ACHV) will report its first quarter financial results and provide an update on its cytisinicline development program on May 12, 2022, at 4:30 PM EDT. Cytisinicline aims to assist in smoking cessation by targeting nicotine receptors in the brain, yet remains an investigational product and is not FDA-approved in the U.S. Tobacco usage leads to over eight million deaths globally each year, highlighting the importance of Achieve's mission. More details can be accessed through their webcast.

Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced a presentation on cytisinicline for smoking cessation at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting in Baltimore, MD, from March 15-18, 2022. The presentation, part of the "Promising New Smoking Cessation Pharmacotherapies" Symposium on March 16 at 3:00 p.m. EDT, aims to highlight the development program for cytisinicline. Cytisinicline is a plant-based alkaloid targeting nicotine addiction, currently in clinical trials and not yet FDA-approved.

Achieve Life Sciences (Nasdaq: ACHV) announced the appointment of Dr. Vaughn Himes to its Board of Directors, effective immediately. Dr. Himes brings over 30 years of experience in the pharmaceutical and biotech industries, currently serving as Chief Technology Officer at Seagen. His expertise will support Achieve's clinical development of cytisinicline, aimed at treating smoking cessation and nicotine addiction. Cytisinicline is a plant-based alkaloid that interacts with nicotine receptors to alleviate withdrawal symptoms, though it remains investigational and not FDA-approved.

Achieve Life Sciences (Nasdaq: ACHV) has expanded its Manufacturing and Quality Operations Team by hiring a Vice President of Process Control and Quality Assurance. The Board approved a stock option grant of 20,000 shares to this new employee, aimed at incentivizing their employment. These options, granted on March 8, 2022, will vest over four years. Achieve is focused on developing cytisinicline, a plant-based treatment for smoking cessation, with topline results from the Phase 3 ORCA-2 clinical trial expected in the first half of 2022, addressing a significant global health issue.

Achieve Life Sciences (Nasdaq: ACHV) announced its financial results for Q4 and year-end 2021, reporting a net loss of $7.2 million for Q4 and $33.2 million for the year. The company initiated the Phase 3 ORCA-3 trial for cytisinicline, targeting 750 smokers at 15 sites, and completed the ORCA-2 trial, with topline results expected in Q2 2022. Achieve secured a $25 million loan facility from Silicon Valley Bank to support its clinical development. As of December 31, 2021, cash reserves were $43.1 million, ensuring operational funding into 2023.

Achieve Life Sciences (NASDAQ: ACHV) announced its participation in the Oppenheimer 32nd Annual Virtual Healthcare Conference on March 15, 2022, at 2:00 PM EDT, and the Maxim 2022 Virtual Growth Conference on March 28, 2022, at 2:30 PM EDT. The company is focused on developing cytisinicline, a plant-based alkaloid aimed at aiding smoking cessation and addressing nicotine addiction. Cytisinicline is not FDA approved for any indication in the U.S. The press release also mentioned the significant global health risks of tobacco use and the potential market for effective cessation therapies.

Achieve Life Sciences (Nasdaq: ACHV) will report its fourth quarter and year-end 2021 financial results on March 10, 2022, at 4:30 PM EST, and provide updates on its cytisinicline development program. Cytisinicline aims to address smoking addiction, a leading cause of preventable deaths globally. It interacts with nicotine receptors in the brain, potentially aiding smoking cessation. Notably, cytisinicline is still investigational and not yet FDA approved. Investors can access the call via the Achieve website or by dialing provided numbers.