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), 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.