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 (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for smoking cessation and nicotine dependence, has announced it will report its second quarter 2024 financial results on August 13, 2024, at 4:30 PM EDT. The company will also provide an update on the cytisinicline development program during the call.
Investors and interested parties can access the webcast through a provided link or join the live conference call by dialing specific numbers for U.S. & Canada or International callers. The conference ID is 13747337. A replay of the webcast will be available approximately three hours after the call and will be archived on the company's website for 90 days.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company specializing in cytisinicline for smoking cessation and nicotine dependence, announced its participation in the JonesHealthcare Seaside Summit 2024. The event will take place from July 14-16, 2024, in Encinitas, CA. CEO John Bencich is scheduled to present on July 15, 2024, at 8:45 AM PDT. Following his presentation, Bencich will join a live panel discussion, "Introducing Disruptive Products to Established Healthcare Markets—Commercial and Regulatory Considerations," at 10:00 AM PDT, moderated by Justin Walsh, PhD, Healthcare Research Analyst at JonesTrading Institutional Services. For more information or to arrange one-on-one meetings, contact JonesTrading or visit Achieve Life Sciences' Investor Relations website.
Achieve Life Sciences (Nasdaq: ACHV) has been added to the U.S. Russell 3000® and Russell Microcap® Indexes, effective July 1, 2024. CEO John Bencich highlighted this as a step to enhance the company's visibility among investors, reflecting solid business fundamentals and market potential for cytisinicline, their treatment for nicotine dependence. Achieve plans to submit a new drug application for smoking cessation in the U.S. in the first half of 2025.
Additionally, Achieve has entered a non-binding term sheet with Silicon Valley Bank to refinance and extend the maturity date of its outstanding term loans. This facility could provide up to $20 million, with interest-only payments through December 31, 2025, maturing on June 1, 2028. The parties expect to close the refinanced loan by August 1, 2024, but there is no guarantee of a definitive agreement.
Achieve Life Sciences has initiated the ORCA-OL clinical trial to evaluate the long-term safety of cytisinicline, a treatment for smoking and nicotine dependence. The open-label trial involves 29 U.S. sites and aims to collect data required for a New Drug Application (NDA) submission expected in the first half of 2025. The study will focus on adults who smoke or use nicotine e-cigarettes, engaging prior ORCA trial participants. It will collect long-term safety data from at least 300 subjects over six months and 100 subjects over one year. Achieve aims to address the FDA's lack of approved treatments for vaping cessation.
Achieve Life Sciences (Nasdaq: ACHV) announced that data from their Phase 2 ORCA-V1 trial will be presented at the Society of General Internal Medicine (SGIM) Annual Meeting in Boston on May 17, 2024. The study, led by Dr. Nancy Rigotti of Harvard Medical School, demonstrated that cytisinicline treatment more than doubled the likelihood of quitting nicotine e-cigarettes compared to placebo. Dr. Rigotti's presentation will occur at 2:45 PM EDT during the 'SAN2: Scientific Abstract Oral Presentations in Mental/Behavioral Health and Substance Use' session. The study was supported by the NIH's National Institute on Drug Abuse.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) reported Q1 2024 financial results, highlighted by positive Phase 2 trial results for cytisinicline in vaping cessation published in JAMA IM, plans to initiate a long-term safety exposure trial, and successful presentations at medical conferences. The company also secured approximately $124.2 million in equity financing to support ongoing clinical development activities. Achieve's cash position stood at $66.4 million as of March 31, 2024, with total operating expenses at $6.0 million and a net loss of $6.5 million for the quarter.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced the publication of ORCA-V1 trial results in JAMA Internal Medicine. The trial showed that treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo, with excellent compliance and safety. Achieve plans to conduct an End-of-Phase 2 Meeting with the FDA to discuss Phase 3 trial plans.
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