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 reports company news around the development and potential commercialization of cytisinicline, an investigational treatment for nicotine dependence. Cytisinicline is a plant-based alkaloid that binds to nicotinic acetylcholine receptors and is being studied for smoking cessation and e-cigarette cessation; it has not been approved by the FDA for any indication in the United States.
Recurring ACHV updates include financial results, clinical data presentations, regulatory and manufacturing progress, supply-chain arrangements for cytisinicline, capital-structure actions, and governance changes. Company announcements also cover scientific publications, board and executive appointments, and operational steps tied to preparing the cytisinicline program for potential commercial use if regulatory approval is obtained.
Achieve Life Sciences has announced the completion of the fifth and final review by the Data Safety Monitoring Committee (DSMC) for its Phase 3 ORCA-2 trial assessing cytisinicline for smoking cessation. The DSMC found no concerns regarding the safety or conduct of the trial, which involved 810 participants across 17 sites. Preliminary data is expected in the first half of 2022, with an emphasis on the potential safety and tolerability of cytisinicline as differentiating factors compared to existing treatments.
Achieve Life Sciences (Nasdaq: ACHV) reported its Q3 2021 financial results, revealing a net loss of $6.7 million for the quarter. The company updated on its ORCA-2 Phase 3 trial, with all 810 subjects having completed treatment, and topline data expected in early 2022. The FDA accepted an IND application for cytisinicline in e-cigarette cessation, with a planned trial (ORCA-V1) to start around Q2 2022. Achieve also received two patents for a novel 3.0 mg TID dosing regimen, expiring in 2040, and expanded its clinical operations team.
Achieve Life Sciences (Nasdaq: ACHV) has announced that its management will hold one-on-one investor meetings at two upcoming conferences in November 2021. The first is at the A.G.P. Biotech & Specialty Pharma Conference on November 10, followed by the Torrey Hills Capital Emerging Growth Conference on November 17. Achieve focuses on developing cytisinicline, a plant-based alkaloid for smoking cessation, which is currently in the Phase 3 ORCA-2 trial, with results expected in the first half of 2022. Cytisinicline has not yet received FDA approval.
Achieve Life Sciences (Nasdaq: ACHV) announced FDA acceptance of an IND application for cytisinicline, targeting e-cigarette cessation treatments. This follows the ongoing Phase 3 trial for combustible cigarette cessation. The ORCA-V1 study, set to begin in Q2 2022, will include 150 adult e-cigarette users, supported by a grant from NIH's NIDA. Recent CDC data shows nearly 11 million adult e-cigarette users in the U.S., with a significant intent to quit. The company also anticipates topline results from its Phase 3 ORCA-2 trial in H1 2022.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) will report its third-quarter 2021 financial results and provide an update on cytisinicline's development on November 9, 2021, at 4:30 PM EST. Cytisinicline targets smoking cessation and nicotine addiction. Tobacco use results in over eight million deaths globally annually. Achieve's cytisinicline interacts with nicotinic receptors to alleviate withdrawal symptoms and reduce the satisfaction of smoking. The company has completed enrollment in the Phase 3 ORCA-2 trial, with topline results expected in early 2022.
Achieve Life Sciences (NASDAQ: ACHV) announced CEO John Bencich's participation in two investor conferences. He will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2021, at 3:45 PM ET and join the Maxim Group's Advances in Mental Health Virtual Conference on the 'Addiction' panel on September 22, 2021, at 9:00 AM ET. Cytisinicline, the company's focus, is a treatment for nicotine addiction, with Phase 3 ORCA-2 trial results expected in the first half of 2022.
Achieve Life Sciences (NASDAQ: ACHV) has announced that data on cytisinicline will be presented at the Society for Research on Nicotine & Tobacco (SRNT-E) Conference from September 15-17, 2021. Key presentations include a subgroup analysis from the ORCA-1 Phase 2 study, showing a Week 4 abstinence rate of 51.3% for cytisinicline, significantly higher than the 15.8% rate for placebo (p=0.009). Another analysis highlighted a shorter time to sustained abstinence with cytisinicline, taking only 7 days compared to 18 days for placebo. Achieve's enrollment in the Phase 3 ORCA-2 trial has been completed, with results expected in early 2022.
Achieve Life Sciences (NASDAQ: ACHV) announced CEO John Bencich's participation in two upcoming investor conferences. The first is a virtual corporate overview at the HC Wainwright 23rd Annual Global Investment Conference on September 13, 2021. The second event is the Lake Street Capital Markets' 5th Annual Best Ideas Growth Conference on September 14-15, 2021, featuring virtual one-on-one investor meetings. Additionally, Achieve recently completed enrollment in the Phase 3 ORCA-2 clinical trial for cytisinicline, with results anticipated in early 2022.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) recently expanded its clinical operations team with key hires, including a Director of Clinical Operations and a Senior Manager of Clinical Trials. This move aims to enhance the development of cytisnicline, a potential treatment for smoking cessation. Achieve has fully enrolled its Phase 3 ORCA-2 trial, targeting combustible cigarette cessation, with results expected in H1 2022. Additionally, the Board approved stock options for new employees, incentivizing their contributions. The firm is committed to addressing nicotine addiction, a major public health issue.
Achieve Life Sciences (ACHV) announced its Q2 2021 financial results, including a net loss of $11.3 million. The company reported the completion of enrollment for the Phase 3 ORCA-2 trial of cytisinicline, involving 810 adult smokers. Achieve secured a $23 million financing and received a NIH grant to evaluate cytisinicline for e-cigarette cessation. Additionally, two new patents were issued for the 3.0 mg TID dosing regimen. Topline data from the ORCA-2 trial is expected in H1 2022.