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 late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. The ACHV news feed highlights company announcements related to its cytisinicline program for smoking cessation in adults and for nicotine e-cigarette or vaping cessation.
News items from Achieve commonly cover clinical and regulatory milestones for cytisinicline, including the acceptance of its New Drug Application by the U.S. Food and Drug Administration (FDA) for smoking cessation, assignment of a Prescription Drug User Fee Act (PDUFA) target action date, and progress in long-term safety trials such as ORCA-OL. Releases also describe Phase 3 efficacy data from ORCA-2 and ORCA-3, Phase 2 results in vaping cessation (ORCA-V1), and post hoc analyses in specific populations such as individuals with chronic obstructive pulmonary disease (COPD).
Investors and observers can use the ACHV news page to follow regulatory designations and programs cited by the company, including Breakthrough Therapy designation for nicotine e-cigarette or vaping cessation and the Commissioner’s National Priority Voucher awarded for cytisinicline. Additional news topics include executive appointments, equity inducement awards, financing transactions disclosed in conjunction with SEC filings, and scheduling of earnings calls and investor meetings.
This page provides a centralized view of Achieve’s press releases and related updates, offering context on how the company describes its progress in advancing cytisinicline as an investigational treatment of nicotine dependence. For those tracking ACHV stock or the development of cytisinicline, the news feed can be revisited regularly to see new clinical, regulatory, and corporate disclosures as they are issued by the company.
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.
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.