Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences (Nasdaq: ACHV) has expanded its Clinical Operations Team with the hire of a new Director of Clinical Operations, as announced on February 3, 2022. To incentivize this recruitment, the Board of Directors approved a stock option grant of 15,000 shares with a per share exercise price equal to the closing price on January 31, 2022. Additionally, the company has completed enrollment in the Phase 3 ORCA-2 clinical trial for cytisinicline, targeting smoking cessation, with topline results expected in the first half of 2022.

Achieve Life Sciences (NASDAQ: ACHV) is participating in the Winter Wonderland Best Ideas Virtual Investor Conference on February 8, 2022, at 2:00 PM EST and the Aegis Virtual Conference on February 25, 2022, also at 2:00 PM EST. The company focuses on developing cytisinicline, a plant-based treatment aimed at smoking cessation and nicotine addiction. Tobacco use is a leading cause of preventable deaths worldwide. Cytisinicline is an investigational product candidate and has yet to receive FDA approval for any use in the U.S. For more details, visit Achieve's website.

Achieve Life Sciences (ACHV) has announced the initiation of screening for the ORCA-3 trial, a crucial Phase 3 study aimed at securing U.S. regulatory approval for cytisinicline, a drug intended for smoking cessation. The trial will assess the safety and efficacy of 3 mg doses administered three times daily, with 750 adult smokers participating across 15 sites. This trial follows the ORCA-2 study, with topline results expected soon. Achieve anticipates significant developments in 2022, including the launch of the ORCA-V1 trial focused on e-cigarette cessation.