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) is hosting a virtual roundtable on November 17, 2020, at 12:00 PM EST to discuss cytisinicline's role in smoking cessation. The event features a principal investigator from the ongoing ORCA-2 Phase 3 trial and a review of results from the RAUORA study comparing cytisinicline to Chantix. Moderated by healthcare analysts, the discussion emphasizes the importance of smoking cessation during the COVID-19 pandemic. Esteemed experts from Harvard, Stanford, and other institutions will participate.
Achieve Life Sciences (NASDAQ: ACHV) announced its invitation to present at the MicroCap Rodeo Best Ideas Bowl, scheduled for October 13-16, 2020. CEO John Bencich will present on October 13 at 3:30 p.m. ET, with one-on-one meetings available throughout the event. The presentation will be webcast live at this link. Achieve is focused on developing cytisinicline, a plant-based solution for smoking cessation, which has helped over 20 million users in Europe.
Achieve Life Sciences (NASDAQ: ACHV) announced the initiation of the Phase 3 ORCA-2 clinical trial, evaluating the efficacy and safety of 3 mg cytisinicline for smoking cessation among 750 adult smokers at 15 U.S. clinical sites. The trial compares two treatment durations against placebo, measuring successful smoking cessation over the final four weeks. Achieve aims to improve quit rates based on previous ORCA-1 findings, with the potential for cytisinicline to be a well-tolerated treatment option if approved.
Achieve Life Sciences (Nasdaq: ACHV) has appointed John Bencich as the new Chief Executive Officer, transitioning from his previous role as Chief Financial and Operating Officer. Cindy Jacobs is promoted to President, while Anthony Clark will continue as Chief Scientific Officer after stepping down from the Board. The company has approximately $26.7 million in cash and plans to initiate the Phase 3 ORCA-2 trial in Q4 2020 for its smoking cessation drug, cytisinicline, which has been used by over 20 million people in Europe.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has announced positive results from the RAUORA trial, comparing cytisinicline to varenicline for smoking cessation among 679 Māori participants. The trial showed cytisinicline met the non-inferiority endpoint with a 4.29% higher quit rate (12.1% vs. 7.9%). Furthermore, cytisinicline demonstrated significantly fewer adverse events (AEs), particularly less nausea (22.5% vs. 39.1%). The trial's findings support the efficacy of cytisinicline and set the stage for the upcoming Phase 3 ORCA-2 trial.
Achieve Life Sciences (NASDAQ: ACHV) presented findings at the SRNT-E Annual Meeting on cytisinicline, a smoking cessation treatment. Research shows that cytisinicline has a significantly lower binding affinity at the 5-HT3 receptor compared to varenicline, which may explain its reduced incidence of nausea and vomiting. Conducted by researchers at the University of Cambridge, the study underscores the importance of side effects on treatment compliance, potentially impacting smoking cessation success. Achieve continues to develop cytisinicline as an effective alternative for nicotine addiction.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced that data on cytisinicline will be presented at the SRNT-E virtual conference on September 18. The presentations will compare cytisinicline to varenicline (Chantix®), highlighting its lower incidence of nausea and vomiting. Cytisinicline, a plant-based treatment approved in Central and Eastern Europe, has helped over 20 million users combat nicotine addiction. Achieve aims to address the global smoking epidemic with this drug, which interacts with nicotine receptors to ease withdrawal symptoms.
Achieve Life Sciences (Nasdaq: ACHV), a clinical-stage pharmaceutical company, announced its participation in two investor conferences: the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, where CFO John Bencich will present at 3:30 PM ET, and the Lake Street Capital Markets 4th Annual Best Ideas Growth Conference on September 17, featuring one-on-one meetings with investors. Achieve focuses on its cytisinicline product, aimed at helping users overcome nicotine addiction.
Achieve Life Sciences (Nasdaq: ACHV) has reported its Q2 2020 financial results, highlighting successful topline results from the RAUORA trial comparing cytisinicline to Chantix. The trial showed cytisinicline was as effective while causing fewer adverse events. Achieve closed a Registered Direct Offering for approximately $6 million and a subsequent Underwritten Public Offering, expected to raise $7.5 million. The company now holds $12.2 million in cash before these offerings. Additionally, a new patent for cytisinicline analogs has been granted, expanding treatment potential for various CNS conditions.
Achieve Life Sciences (Nasdaq: ACHV) has announced a public offering of 476,187 shares of its common stock at $10.50 per share, aiming to raise approximately $6.5 million. The offering also includes pre-funded warrants for investors whose holdings may exceed 9.99% after the offering. The funds will be directed towards clinical research and general working capital. This offering, managed by Lake Street Capital Markets LLC, is expected to close around August 6, 2020. The company focuses on developing cytisinicline for smoking cessation.
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