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 (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.
Achieve Life Sciences (Nasdaq: ACHV) has successfully closed a public offering of 2,472,500 shares at $7.00 each, raising $17.3 million before expenses. The offering included the underwriter's full over-allotment of 322,500 shares. Proceeds will support the Phase 3 ORCA-2 trial, clinical research, and general corporate needs, extending the company's financial runway into mid-2022. Lake Street Capital Markets was the sole bookrunning manager, and the registration was declared effective by the SEC on December 2, 2020.
Achieve Life Sciences (Nasdaq: ACHV) announced a public offering of 2,150,000 shares at $7.00 each, aiming to raise approximately $15 million. The offering, set to close around December 7, 2020, includes a 30-day option for underwriters to purchase an additional 322,500 shares. Proceeds will fund the Phase 3 ORCA-2 trial and support clinical research and corporate purposes. This offering follows a recent SEC registration, positioning Achieve to enhance its development of cytisinicline, a promising aid for smoking cessation.
Achieve Life Sciences (Nasdaq: ACHV) announced a proposed underwritten public offering of 1,500,000 shares of common stock, along with an option for underwriters to purchase an additional 225,000 shares. The offering, managed by Lake Street Capital Markets LLC with Maxim Group LLC as co-manager, aims to fund the Phase 3 ORCA-2 trial and support clinical research, development, and general corporate purposes. A registration statement has been filed with the SEC, but the completion and terms of the offering remain uncertain due to market conditions.
Achieve Life Sciences (Nasdaq: ACHV) reported Q3 2020 financial results, highlighting the initiation of the Phase 3 ORCA-2 trial for cytisinicline, aimed at smoking cessation. The trial involves 750 smokers and compares cytisinicline's efficacy against placebo. The company announced a cash position of $22.4 million with Q3 operating expenses of $3.8 million, leading to a net loss of $3.8 million. Cytisinicline showed promising results in a previous trial against Chantix, revealing fewer adverse events and higher quit rates. A virtual roundtable on smoking cessation is scheduled for November 17, 2020.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) will release its third quarter 2020 financial results on November 12, 2020, at 4:30 PM ET. The company is focused on the development of cytisinicline for smoking cessation and nicotine addiction. The earnings call will provide updates on this program, and interested parties can access the call via their Investor Relations page or by phone. A replay will be available approximately two hours after the call.
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