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) 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.
Achieve Life Sciences, Inc. (NASDAQ:ACHV) will report its second quarter 2021 financial results on August 12, 2021, at 4:30 PM EDT. The conference will provide an update on the cytisinicline development program, aimed at addressing smoking cessation and nicotine addiction. Investors can join the live conference call by dialing (877) 472-9809 in the U.S. or (629) 228-0791 internationally, referencing conference ID 8694398. A webcast replay will be available on Achieve's Investor Relations page approximately two hours post-call.
Achieve Life Sciences (NASDAQ: ACHV) has received a grant from the National Institute on Drug Abuse (NIDA) to explore cytisinicline for nicotine e-cigarette cessation. Set to begin on August 1, 2021, the grant will support vital regulatory and clinical activities, including submitting a new IND to the FDA. The anticipated Phase 2 ORCA-V1 study will involve about 150 adult e-cigarette users in the U.S. Achieve has also completed enrollment for its Phase 3 ORCA-2 trial for combustible cigarette cessation, with top-line results expected in early 2022.
Achieve Life Sciences (NASDAQ: ACHV) has announced the completion of participant enrollment for its Phase 3 ORCA-2 trial of cytisinicline, targeting 750 adult smokers in the U.S. This trial will compare the drug's effectiveness and safety against placebo for smoking cessation. Participants will take 3 mg of cytisinicline three times daily for either 6 or 12 weeks, with monitoring extending to 24 weeks post-randomization. Topline results are expected in the first half of 2022, with prior studies showing promising results for cytisinicline.
Achieve Life Sciences (NASDAQ: ACHV) announced the allowance of two U.S. patent applications covering a novel 3.0 mg three times daily cytisinicline dosing regimen for nicotine addiction treatment. These patents will protect the administration method, potentially enhancing its intellectual property strategy as cytisinicline undergoes clinical trials. The Phase 3 ORCA-2 trial is ongoing, with a 50% quit rate observed in prior studies. Patents are expected to expire in Q3 2040, and the company aims for FDA approval, which could link the patents to the FDA's Orange Book.
Achieve Life Sciences, a clinical-stage pharmaceutical company, will participate in the LD Micro Invitational XI Conference from June 8-10, 2021. CEO John Bencich is set to present virtually on June 9 at 2:30 p.m. EDT. The event will feature around 180 companies and will run daily from 10 a.m. to 6 p.m. EDT. Achieve is focused on developing cytisinicline for smoking cessation, a plant-based alkaloid that assists with nicotine addiction. Currently, a Phase 3 study (ORCA-2) is enrolling participants across 17 U.S. sites.
Achieve Life Sciences (Nasdaq: ACHV) has successfully closed a public offering, issuing 3,285,714 shares of common stock at a price of $7.00 per share. This results in gross proceeds of $23.0 million destined for ongoing development of cytisinicline, clinical research, and corporate purposes. The offering included 428,571 additional shares from underwriters' exercised options. The securities were registered with the SEC, and the company continues to focus on combating nicotine addiction through its investigational product, cytisinicline, currently in Phase 3 trials.