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) 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.
Achieve Life Sciences (Nasdaq: ACHV) announced a proposed underwritten public offering of its common stock to fund clinical research and general working capital. The offering includes pre-funded warrants for certain investors owning more than 9.99% of shares post-offering. Lake Street Capital Markets is the sole book-running manager, and underwriters may purchase an additional 15% of the shares. The offering is subject to market conditions and details will be filed with the SEC. Achieve aims to combat nicotine addiction through its product, cytisinicline, already used by over 20 million people.
Achieve Life Sciences (NASDAQ: ACHV) announced on July 31, 2020, that it has received a patent (US 2020/0172544 A1) for novel analogs of cytisinicline, aimed at treating CNS and addictive disorders. Cytisinicline is a partial agonist of nicotinic acetylcholine receptors, potentially effective for conditions like Alzheimer’s and nicotine addiction. The company emphasizes its commitment to expanding its intellectual property portfolio while addressing smoking cessation. The press release cautions that achieving its goals may face various risks, including regulatory approvals and market conditions.
Achieve Life Sciences (Nasdaq: ACHV), a clinical-stage pharmaceutical company, will report its second-quarter 2020 financial results on August 6, 2020. The company is focused on the development of cytisinicline for smoking cessation and nicotine addiction. Following the release, management will host a conference call at 4:30 PM ET to discuss the results and provide updates on the cytisinicline clinical development program. Investors can access the call via the Investor Relations page or through a dedicated conference call line.
Achieve Life Sciences (Nasdaq: ACHV) announced a $6 million registered direct offering for 14,634,146 shares of common stock at $0.41 per share. The transaction is set to close around July 1, 2020, pending customary conditions. Proceeds will fund clinical research and development, along with general working capital. The offering is conducted under the effective shelf registration statement filed with the SEC. Lake Street Capital Markets LLC serves as the exclusive placement agent for this offering.
Achieve Life Sciences (Nasdaq: ACHV) announced successful topline results from the RAUORA Phase 3 trial, comparing cytisinicline to varenicline for smoking cessation. Conducted in New Zealand, the trial involved 679 participants and demonstrated that cytisinicline was at least as effective as varenicline, with significantly fewer adverse effects. The trial results suggest a promising future for cytisinicline in addressing nicotine addiction, especially among Māori populations. Full results are expected to be presented at the SRNT-E Annual Meeting in September 2020.
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