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Stock impact report

Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA [Yahoo! Finance]

Achieve Life Sciences, Inc. - Common Shares (ACHV) 
Last achieve life sciences, inc. - common shares earnings: 3/13 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.achievelifesciences.com
Company Research Source: Yahoo! Finance
The FDA agreed on the proposed single Phase 3 study design and additional requirements for submitting a supplemental new drug application. The Phase 3 ORCA-V2 trial will assess the efficacy and safety of cytisinicline in approximately 800 adults who use e-cigarettes or nicotine vapes and do not currently smoke cigarettes. The trial is expected to initiate in the third quarter of 2025. Cytisinicline has been granted Breakthrough Therapy designation to address the critical need for a treatment for nicotine e-cigarette cessation, with no FDA-approved treatments currently available. Milestone Reinforces the Potential for Cytisinicline as a First-in-Class Treatment for Vaping Cessation SEATTLE and VANCOUVER, British Columbia, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for nicotine dependence, announced today the successful outcome of its End-of-Phase Show less Read more
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