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 the initiation of the Phase 3 ORCA-2 clinical trial, evaluating the efficacy and safety of 3 mg cytisinicline for smoking cessation among 750 adult smokers at 15 U.S. clinical sites. The trial compares two treatment durations against placebo, measuring successful smoking cessation over the final four weeks. Achieve aims to improve quit rates based on previous ORCA-1 findings, with the potential for cytisinicline to be a well-tolerated treatment option if approved.
Achieve Life Sciences (Nasdaq: ACHV) has appointed John Bencich as the new Chief Executive Officer, transitioning from his previous role as Chief Financial and Operating Officer. Cindy Jacobs is promoted to President, while Anthony Clark will continue as Chief Scientific Officer after stepping down from the Board. The company has approximately $26.7 million in cash and plans to initiate the Phase 3 ORCA-2 trial in Q4 2020 for its smoking cessation drug, cytisinicline, which has been used by over 20 million people in Europe.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has announced positive results from the RAUORA trial, comparing cytisinicline to varenicline for smoking cessation among 679 Māori participants. The trial showed cytisinicline met the non-inferiority endpoint with a 4.29% higher quit rate (12.1% vs. 7.9%). Furthermore, cytisinicline demonstrated significantly fewer adverse events (AEs), particularly less nausea (22.5% vs. 39.1%). The trial's findings support the efficacy of cytisinicline and set the stage for the upcoming Phase 3 ORCA-2 trial.
Achieve Life Sciences (NASDAQ: ACHV) presented findings at the SRNT-E Annual Meeting on cytisinicline, a smoking cessation treatment. Research shows that cytisinicline has a significantly lower binding affinity at the 5-HT3 receptor compared to varenicline, which may explain its reduced incidence of nausea and vomiting. Conducted by researchers at the University of Cambridge, the study underscores the importance of side effects on treatment compliance, potentially impacting smoking cessation success. Achieve continues to develop cytisinicline as an effective alternative for nicotine addiction.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced that data on cytisinicline will be presented at the SRNT-E virtual conference on September 18. The presentations will compare cytisinicline to varenicline (Chantix®), highlighting its lower incidence of nausea and vomiting. Cytisinicline, a plant-based treatment approved in Central and Eastern Europe, has helped over 20 million users combat nicotine addiction. Achieve aims to address the global smoking epidemic with this drug, which interacts with nicotine receptors to ease withdrawal symptoms.
Achieve Life Sciences (Nasdaq: ACHV), a clinical-stage pharmaceutical company, announced its participation in two investor conferences: the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, where CFO John Bencich will present at 3:30 PM ET, and the Lake Street Capital Markets 4th Annual Best Ideas Growth Conference on September 17, featuring one-on-one meetings with investors. Achieve focuses on its cytisinicline product, aimed at helping users overcome nicotine addiction.
Achieve Life Sciences (Nasdaq: ACHV) has reported its Q2 2020 financial results, highlighting successful topline results from the RAUORA trial comparing cytisinicline to Chantix. The trial showed cytisinicline was as effective while causing fewer adverse events. Achieve closed a Registered Direct Offering for approximately $6 million and a subsequent Underwritten Public Offering, expected to raise $7.5 million. The company now holds $12.2 million in cash before these offerings. Additionally, a new patent for cytisinicline analogs has been granted, expanding treatment potential for various CNS conditions.
Achieve Life Sciences (Nasdaq: ACHV) has announced a public offering of 476,187 shares of its common stock at $10.50 per share, aiming to raise approximately $6.5 million. The offering also includes pre-funded warrants for investors whose holdings may exceed 9.99% after the offering. The funds will be directed towards clinical research and general working capital. This offering, managed by Lake Street Capital Markets LLC, is expected to close around August 6, 2020. The company focuses on developing cytisinicline for smoking cessation.
Achieve Life Sciences (Nasdaq: ACHV) announced a proposed underwritten public offering of its common stock to fund clinical research and general working capital. The offering includes pre-funded warrants for certain investors owning more than 9.99% of shares post-offering. Lake Street Capital Markets is the sole book-running manager, and underwriters may purchase an additional 15% of the shares. The offering is subject to market conditions and details will be filed with the SEC. Achieve aims to combat nicotine addiction through its product, cytisinicline, already used by over 20 million people.
Achieve Life Sciences (NASDAQ: ACHV) announced on July 31, 2020, that it has received a patent (US 2020/0172544 A1) for novel analogs of cytisinicline, aimed at treating CNS and addictive disorders. Cytisinicline is a partial agonist of nicotinic acetylcholine receptors, potentially effective for conditions like Alzheimer’s and nicotine addiction. The company emphasizes its commitment to expanding its intellectual property portfolio while addressing smoking cessation. The press release cautions that achieving its goals may face various risks, including regulatory approvals and market conditions.