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, 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.
Achieve Life Sciences (Nasdaq: ACHV) announced the presentation of three posters at the SRNT Annual Meeting on February 24, 2021. The data highlighted the low satisfaction levels among smokers concerning current cessation treatments and indicated that over 75% of Chantix users do not complete the recommended therapy course. Additionally, 73% of e-cigarette users plan to quit vaping within the next year. Achieve is enrolling participants for the Phase 3 ORCA-2 study of cytisinicline, a potential new treatment for nicotine addiction.
Achieve Life Sciences (NASDAQ: ACHV) will present at the MicroCap Rodeo Winter Wonderland Conference from February 16-19, 2021. CEO John Bencich is scheduled to speak on February 16 at 12:30 p.m. EST. The presentation will be available for live streaming and replay at their investor relations site.
The conference highlights 35 investment opportunities recommended by institutional investors, focusing on companies like Achieve, which is dedicated to resolving nicotine addiction through its product, cytisinicline.
Achieve Life Sciences (NASDAQ:ACHV) will have CEO John Bencich present at the H.C. Wainwright BioConnect Conference from January 11-14, 2021. The presentation will be available via webcast starting January 11 at 6:00 AM EST on the Achieve Investor Relations page. The company focuses on developing cytisinicline, a plant-based treatment for nicotine addiction, which is approved in Central and Eastern Europe and has helped over 20 million users. Smoking remains a leading cause of preventable death worldwide, emphasizing the importance of Achieve’s mission.
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