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) has successfully closed a public offering, issuing 3,285,714 shares of common stock at a price of $7.00 per share. This results in gross proceeds of $23.0 million destined for ongoing development of cytisinicline, clinical research, and corporate purposes. The offering included 428,571 additional shares from underwriters' exercised options. The securities were registered with the SEC, and the company continues to focus on combating nicotine addiction through its investigational product, cytisinicline, currently in Phase 3 trials.
Achieve Life Sciences (NASDAQ: ACHV) has announced a public offering of 2,857,143 shares of its common stock at $7.00 per share, aiming to raise approximately $20 million. The offering is slated to close on or around May 27, 2021. Proceeds will be allocated to the ongoing development of cytisinicline, clinical research, and general corporate purposes. The offering is managed by Oppenheimer & Co. Inc. and Lake Street Capital Markets. A registration statement has been filed and declared effective by the SEC.
Achieve Life Sciences (NASDAQ:ACHV) has announced a proposed underwritten public offering of its common stock, including a 30-day option for underwriters to purchase an additional 15%. The company plans to utilize proceeds for ongoing development of cytisinicline, a treatment for smoking cessation, along with other corporate purposes. The offering is subject to market conditions, and there is no guarantee regarding its timing or completion. Oppenheimer & Co. is the sole book-running manager for the offering.
Achieve Life Sciences (NASDAQ:ACHV) reported Q1 2021 financial results, revealing a net loss of $8.0 million on total operating expenses of $8.0 million. As of March 31, 2021, the company's cash reserves totaled $29.7 million. The Phase 3 ORCA-2 trial for cytisinicline is progressing with enrollment expected to complete by mid-2021. Promising results from the Phase 2b ORCA-1 trial showed significant smoking cessation benefits. Additionally, cytisinicline demonstrated non-inferiority to Chantix in the RAUORA trial. New board members, Dr. Martell and Dr. Jacobs, were appointed, enhancing leadership expertise.
Achieve Life Sciences, Inc. (Nasdaq:ACHV) will announce its first quarter 2021 financial results and provide updates on the cytisinicline development program on May 13, 2021, at 4:30 PM EDT. Interested parties can join the live webcast via the company's Investor Relations page or by calling (877) 472-9809 in the U.S. and Canada. A replay will be available after the call, archived for 90 days.
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.
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