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, Inc. (Nasdaq: ACHV) is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. The ACHV news feed highlights company announcements related to its cytisinicline program for smoking cessation in adults and for nicotine e-cigarette or vaping cessation.
News items from Achieve commonly cover clinical and regulatory milestones for cytisinicline, including the acceptance of its New Drug Application by the U.S. Food and Drug Administration (FDA) for smoking cessation, assignment of a Prescription Drug User Fee Act (PDUFA) target action date, and progress in long-term safety trials such as ORCA-OL. Releases also describe Phase 3 efficacy data from ORCA-2 and ORCA-3, Phase 2 results in vaping cessation (ORCA-V1), and post hoc analyses in specific populations such as individuals with chronic obstructive pulmonary disease (COPD).
Investors and observers can use the ACHV news page to follow regulatory designations and programs cited by the company, including Breakthrough Therapy designation for nicotine e-cigarette or vaping cessation and the Commissioner’s National Priority Voucher awarded for cytisinicline. Additional news topics include executive appointments, equity inducement awards, financing transactions disclosed in conjunction with SEC filings, and scheduling of earnings calls and investor meetings.
This page provides a centralized view of Achieve’s press releases and related updates, offering context on how the company describes its progress in advancing cytisinicline as an investigational treatment of nicotine dependence. For those tracking ACHV stock or the development of cytisinicline, the news feed can be revisited regularly to see new clinical, regulatory, and corporate disclosures as they are issued by the company.
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.
Achieve Life Sciences (NASDAQ:ACHV) announced the issuance of two patents by the USPTO for a 3.0 mg TID dosing regimen of cytisinicline, a treatment for nicotine addiction. The patents could provide marketing exclusivity until 2040, enhancing the company’s position in the smoking cessation market. Results from the ongoing Phase 3 ORCA-2 trial are expected in early 2022.