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 announced a private placement of securities, raising approximately $18.9 million to support the development of cytisinicline for smoking cessation. The placement consists of 4,093,141 units at $4.625 per unit, with an 8.6% premium over the previous closing price. Proceeds will fund clinical research and working capital, estimated to maintain operations into late 2023. The placement is led by Lake Street Capital Markets, ensuring investment from both new and existing investors.
Achieve Life Sciences (NASDAQ: ACHV) reported its third quarter 2022 financial results on November 14, announcing the completion of targeted enrollment in key clinical trials for cytisinicline, a smoking cessation treatment. The Phase 3 ORCA-3 trial enrolled 750 adult smokers, while the Phase 2 ORCA-V1 trial for e-cigarette users completed early enrollment with 150 participants. Financially, the company recorded a net loss of $13.1 million for Q3 and held $18.2 million in cash as of September 30, 2022. Top-line data from both trials is expected in Q2 2023.
Achieve Life Sciences has successfully reached target enrollment for the Phase 2 ORCA-V1 clinical trial of cytisinicline, aimed at aiding adults dependent on nicotine vaping to quit. This randomized, placebo-controlled trial will treat 150 participants, measuring efficacy and safety over 12 weeks. Positive results from the prior ORCA-2 trial demonstrated significant quit rates among smokers. Topline results from ORCA-V1 are anticipated in the first half of 2023, supported by grant funding from the National Institute on Drug Abuse.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) is set to report its third quarter financial results on November 14, 2022, at 4:30 PM EST. The announcement will provide updates on the development of cytisinicline, an investigational treatment aimed at aiding smoking cessation and nicotine dependence. Presently, there are no FDA-approved treatments for nicotine e-cigarette cessation. Achieve's efforts focus on addressing the global nicotine addiction epidemic, which contributes to over 8 million deaths annually worldwide due to tobacco use.
Achieve Life Sciences has successfully completed enrollment for 750 participants in its Phase 3 ORCA-3 trial, evaluating the efficacy and safety of cytisinicline in smoking cessation among adult smokers in the U.S. The trial compares 3 mg cytisinicline dosed three times daily against placebo over 6 or 12 weeks. Topline results are expected in the first half of 2023. If successful, this could lead to FDA approval, making it the first non-nicotine smoking cessation treatment available in almost 20 years, following positive results from the earlier ORCA-2 trial.
Achieve Life Sciences (NASDAQ: ACHV) announced participation in the Lake Street Best Ideas Growth Conference and the Ladenburg Thalmann Healthcare Conference, aimed at promoting cytisinicline, a treatment for smoking cessation. The Lake Street conference is set for September 14, 2022, featuring one-on-one meetings, while the Ladenburg Thalmann conference will include a presentation on September 29, 2022. Achieve's cytisinicline targets nicotine addiction amid rising e-cigarette use and smoking-related health risks, with the drug currently under investigation.
Achieve Life Sciences (ACHV) announced its Q2 2022 financial results, highlighting significant milestones in its clinical program for cytisinicline.
The Phase 3 ORCA-2 trial showed statistically significant results with increased quit rates, 6-8 times higher than placebo. The company was also awarded a $2.5 million NIH grant for the ORCA-V1 Phase 2 trial targeting nicotine e-cigarette users. Financially, Achieve reported a net loss of $10.5 million for Q2, with cash reserves of $29.4 million as of June 30, 2022. A conference call is scheduled for August 11, 2022, at 4:30 PM EDT.
Achieve Life Sciences (NASDAQ: ACHV) will release its second quarter financial results on August 11, 2022, at 4:30 PM EDT. The focus will be on the development of cytisinicline, a plant-based treatment for smoking cessation. Tobacco-related diseases result in over 8 million deaths globally each year. Cytisinicline aims to address nicotine addiction by acting on brain receptors to ease withdrawal symptoms and reduce cravings. The product is still under investigation and has not yet received FDA approval.
Achieve Life Sciences (Nasdaq: ACHV) announced the issuance of stock options to two new employees as inducement grants. The Board approved a total of 15,000 shares for purchase on June 29, 2022. This action aligns with Nasdaq Listing Rule 5635(c)(4), emphasizing the company's commitment to attracting talent. The options will vest over four years, starting with 25% after the first year of employment. Achieve focuses on developing cytisinicline for smoking cessation, targeting a significant public health issue amid the global nicotine addiction epidemic.
Achieve Life Sciences (Nasdaq: ACHV) has initiated subject screening for its ORCA-V1 Phase 2 clinical trial, testing 3mg cytisinicline in 150 adult e-cigarette users across five U.S. locations. Funded by a $2.8 million grant from the National Institute on Drug Abuse, the trial will assess efficacy versus placebo over 12 weeks. The ORCA-2 trial previously yielded positive results, showing up to eight times higher quit rates for smokers using cytisinicline compared to placebo. Achieve is also advancing its Phase 3 ORCA-3 trial targeting combustible cigarette cessation.