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) 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.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) will host a Virtual Non-Deal Roadshow on April 27, 2021, at 9:00 AM EDT. CEO John Bencich will present the company’s plans and participate in a Q&A with Zacks Analyst John Vandermosten. This event aims to inform on Achieve’s development of cytisinicline, a plant-based treatment for smoking cessation, which is currently in a Phase 3 clinical trial (ORCA-2) involving 750 subjects across 16 U.S. sites. Cytisinicline targets nicotine addiction by interacting with brain receptors. For more details, visit Achieve's website.
Achieve Life Sciences (ACHV) announces the publication of Phase 2b ORCA-1 trial results, demonstrating that cytisinicline is statistically significantly more effective than placebo in aiding smoking cessation. Participants on the 3.0 mg cytisinicline thrice daily regimen were 5 times more likely to achieve abstinence (p<0.001). The drug showed a favorable safety profile with no serious adverse events reported. The ongoing Phase 3 ORCA-2 trial is currently enrolling participants across 16 sites in the U.S. for further evaluation of cytisinicline's effectiveness.
Achieve Life Sciences (NASDAQ: ACHV) announced the publication of Phase 3 RAUORA trial results in Addiction, showing that subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months than those on varenicline. The trial involved 679 Māori participants and demonstrated non-inferiority with a trending superiority of cytisinicline. Fewer side effects were reported, supporting its potential as a viable smoking cessation treatment. Achieve is also enrolling in the ongoing ORCA-2 study to further explore cytisinicline's efficacy.
Achieve Life Sciences (NASDAQ: ACHV), a clinical-stage pharmaceutical firm, will present at the Emerging Growth Virtual Conference from March 17-19, 2021. CEO John Bencich is invited to lead discussions on their product, cytisinicline, aimed at combating nicotine addiction—a major health crisis linked to millions of deaths globally. Cytisinicline is under development as an investigational treatment for smoking cessation. The conference includes various interactive sessions featuring CEOs and investors.
Achieve Life Sciences, Inc. (NASDAQ:ACHV) announced the immediate appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to its Board of Directors. Dr. Martell is recognized for her extensive clinical development expertise, while Dr. Jacobs continues her role as President and Chief Medical Officer. Both bring significant experience in addiction medicine, which aligns with Achieve's mission to develop cytisinicline for smoking cessation. Cytisinicline targets nicotine addiction, although it has not yet received FDA approval. This strategic leadership move aims to bolster the company’s efforts in addressing global nicotine addiction.
Achieve Life Sciences (ACHV) announced its fourth quarter and year-end 2020 results. The company is advancing the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation, targeting 750 adult smokers across 15 U.S. sites. In 2020, Achieve raised $17.3 million through a public offering, enhancing its financial position with cash reserves of $35.9 million by year-end. However, the company reported a fourth-quarter net loss of $4.7 million. Data from the SRNT Annual Meeting revealed low satisfaction with current cessation treatments, indicating a market need for effective alternatives.
Achieve Life Sciences, Inc. (NASDAQ:ACHV) will announce its fourth quarter and year-end 2020 financial results on March 11, 2021, at 4:30 PM ET. The company is focused on the global development of cytisinicline for smoking cessation and nicotine addiction. Interested parties can access the conference call via the Investor Relations page on the Achieve website or by dialing in. A replay will be available after the call. This marks a significant opportunity for stakeholders to assess the company's financial health and developments in their product pipeline.