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 specialty pharmaceutical company dedicated to addressing the global nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid intended for smoking and e-cigarette cessation. The company's main focus is advancing cytisinicline as a viable treatment option to help individuals overcome nicotine dependence, a significant public health concern affecting millions worldwide.
Headquartered in Seattle, Washington, and Vancouver, British Columbia, Achieve Life Sciences has made notable strides in its clinical development programs. The company has successfully completed two Phase 3 trials (ORCA-2 and ORCA-3) and a Phase 2 trial (ORCA-V1) for e-cigarette cessation. Cytisinicline has demonstrated a strong safety profile and statistical significance in increasing the likelihood of quitting nicotine compared to placebo.
In February 2024, Achieve announced a substantial $124.2 million financing, enabling the company to further its clinical development, particularly the long-term exposure trial (ORCA-OL), which is critical for its New Drug Application (NDA) submission anticipated in the first half of 2025. This financing also involves participation from strategic investors such as Propel Bio Partners LLC, Nantahala Capital, and Sopharma, among others.
The company recently announced positive outcomes from its Phase 2 ORCA-V1 trial, where cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo. These results were published in the Journal of the American Medical Association (JAMA) Internal Medicine, further cementing cytisinicline's potential as a breakthrough treatment in nicotine cessation.
Achieve Life Sciences collaborates with key industry stakeholders and regulatory bodies like the U.S. Food and Drug Administration (FDA) to ensure the comprehensive evaluation of cytisinicline's efficacy and safety. The company is on track to begin the ORCA-OL trial in the second quarter of 2024, with results expected to support its NDA submission and potential FDA approval by 2025.
As of March 31, 2024, the company reported cash and cash equivalents totaling $66.4 million, reflecting its strong financial position post the recent equity financing. Achieve Life Sciences remains committed to its mission of providing effective treatment solutions for nicotine addiction and improving public health outcomes globally.
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.
FAQ
What is the current stock price of Achieve Life Sciences (ACHV)?
What is the market cap of Achieve Life Sciences (ACHV)?
What is the main focus of Achieve Life Sciences?
What is cytisinicline?
What recent clinical trials has Achieve Life Sciences completed?
What were the results of the Phase 2 ORCA-V1 trial?
What is the purpose of the ORCA-OL trial?
How is Achieve Life Sciences funded?
When does Achieve Life Sciences plan to submit the NDA for cytisinicline?
Who are the key investors in the recent financing round for Achieve Life Sciences?
What is the current financial status of Achieve Life Sciences?
What are the next steps for cytisinicline's development?
