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, 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.
Achieve Life Sciences (NASDAQ: ACHV) has announced a public offering of 2,857,143 shares of its common stock at $7.00 per share, aiming to raise approximately $20 million. The offering is slated to close on or around May 27, 2021. Proceeds will be allocated to the ongoing development of cytisinicline, clinical research, and general corporate purposes. The offering is managed by Oppenheimer & Co. Inc. and Lake Street Capital Markets. A registration statement has been filed and declared effective by the SEC.
Achieve Life Sciences (NASDAQ:ACHV) has announced a proposed underwritten public offering of its common stock, including a 30-day option for underwriters to purchase an additional 15%. The company plans to utilize proceeds for ongoing development of cytisinicline, a treatment for smoking cessation, along with other corporate purposes. The offering is subject to market conditions, and there is no guarantee regarding its timing or completion. Oppenheimer & Co. is the sole book-running manager for the offering.
Achieve Life Sciences (NASDAQ:ACHV) reported Q1 2021 financial results, revealing a net loss of $8.0 million on total operating expenses of $8.0 million. As of March 31, 2021, the company's cash reserves totaled $29.7 million. The Phase 3 ORCA-2 trial for cytisinicline is progressing with enrollment expected to complete by mid-2021. Promising results from the Phase 2b ORCA-1 trial showed significant smoking cessation benefits. Additionally, cytisinicline demonstrated non-inferiority to Chantix in the RAUORA trial. New board members, Dr. Martell and Dr. Jacobs, were appointed, enhancing leadership expertise.
Achieve Life Sciences, Inc. (Nasdaq:ACHV) will announce its first quarter 2021 financial results and provide updates on the cytisinicline development program on May 13, 2021, at 4:30 PM EDT. Interested parties can join the live webcast via the company's Investor Relations page or by calling (877) 472-9809 in the U.S. and Canada. A replay will be available after the call, archived for 90 days.