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 has received a $2.5 million grant from the National Institute on Drug Abuse (NIDA) to fund the initiation of the Phase 2 ORCA-V1 clinical trial. This trial will assess the efficacy and safety of cytisinicline in around 150 adult users of nicotine e-cigarettes at five locations in the U.S. The total awarded funding now amounts to $2.8 million, covering about half the trial's costs. Notably, cytisinicline has shown promising results in previous studies, and there is a significant market opportunity as over 10 million U.S. adults use e-cigarettes.
Achieve Life Sciences (NASDAQ: ACHV) is set to participate in the LD Micro Invitational Conference from June 7-9, 2022, at the Four Seasons in Westlake Village, CA. The presentation scheduled for June 7 at 7:30 AM PDT will also be available for virtual viewing. Achieve focuses on developing cytisinicline, a plant-based compound aimed at aiding smoking cessation and addressing nicotine addiction. Tobacco use causes over 8 million deaths globally each year, highlighting the significance of Achieve's mission. Cytisinicline has not yet received FDA approval.
Achieve Life Sciences (NASDAQ: ACHV), a clinical-stage pharmaceutical firm, will participate in the Spring Into Action Best Ideas Virtual Investor Conference from May 16-20, 2022. Achieve focuses on the development of cytisinicline, a plant-based product aimed at smoking cessation and nicotine addiction. This investigational candidate has not yet received FDA approval. With tobacco-related deaths exceeding eight million globally, cytisinicline aims to mitigate this crisis by targeting nicotine receptors in the brain. For access to the conference, registration is required.
Achieve Life Sciences (Nasdaq: ACHV) reported strong first quarter 2022 results, highlighting significant outcomes from the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation. The trial showed a 32.6% abstinence rate at weeks 9-12 for those on cytisinicline, compared to 7.0% for placebo. The company gained access to an additional $10 million in funding via a revised agreement with Silicon Valley Bank. Achieve ended the quarter with $36.4 million in cash and reported a net loss of $7.6 million on operating expenses of $7.2 million.
Achieve Life Sciences (NASDAQ: ACHV) announced positive topline results from the Phase 3 ORCA-2 trial for cytisinicline, showing significant efficacy in smoking cessation. Participants receiving 12 weeks of treatment demonstrated a 6.3x higher likelihood of quitting smoking compared to placebo, while those receiving 6 weeks showed an 8x increase. Continuous abstinence rates were 21.1% and 8.9% respectively after treatment. The trial highlighted cytisinicline's safety with low adverse event rates. Achieve is seeking FDA approval for this potential breakthrough in smoking cessation therapy.
Achieve Life Sciences (Nasdaq: ACHV) will report its first quarter financial results and provide an update on its cytisinicline development program on May 12, 2022, at 4:30 PM EDT. Cytisinicline aims to assist in smoking cessation by targeting nicotine receptors in the brain, yet remains an investigational product and is not FDA-approved in the U.S. Tobacco usage leads to over eight million deaths globally each year, highlighting the importance of Achieve's mission. More details can be accessed through their webcast.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced a presentation on cytisinicline for smoking cessation at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting in Baltimore, MD, from March 15-18, 2022. The presentation, part of the "Promising New Smoking Cessation Pharmacotherapies" Symposium on March 16 at 3:00 p.m. EDT, aims to highlight the development program for cytisinicline. Cytisinicline is a plant-based alkaloid targeting nicotine addiction, currently in clinical trials and not yet FDA-approved.
Achieve Life Sciences (Nasdaq: ACHV) announced the appointment of Dr. Vaughn Himes to its Board of Directors, effective immediately. Dr. Himes brings over 30 years of experience in the pharmaceutical and biotech industries, currently serving as Chief Technology Officer at Seagen. His expertise will support Achieve's clinical development of cytisinicline, aimed at treating smoking cessation and nicotine addiction. Cytisinicline is a plant-based alkaloid that interacts with nicotine receptors to alleviate withdrawal symptoms, though it remains investigational and not FDA-approved.
Achieve Life Sciences (Nasdaq: ACHV) has expanded its Manufacturing and Quality Operations Team by hiring a Vice President of Process Control and Quality Assurance. The Board approved a stock option grant of 20,000 shares to this new employee, aimed at incentivizing their employment. These options, granted on March 8, 2022, will vest over four years. Achieve is focused on developing cytisinicline, a plant-based treatment for smoking cessation, with topline results from the Phase 3 ORCA-2 clinical trial expected in the first half of 2022, addressing a significant global health issue.
Achieve Life Sciences (Nasdaq: ACHV) announced its financial results for Q4 and year-end 2021, reporting a net loss of $7.2 million for Q4 and $33.2 million for the year. The company initiated the Phase 3 ORCA-3 trial for cytisinicline, targeting 750 smokers at 15 sites, and completed the ORCA-2 trial, with topline results expected in Q2 2022. Achieve secured a $25 million loan facility from Silicon Valley Bank to support its clinical development. As of December 31, 2021, cash reserves were $43.1 million, ensuring operational funding into 2023.