Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA
Achieve Life Sciences, Inc. - Common Shares (ACHV)
Last achieve life sciences, inc. - common shares earnings: 3/13 08:00 am
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US:NASDAQ Investor Relations:
ir.achievelifesciences.com
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Source: GlobeNewswire
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 2 meeting with the U.S. Food and Drug Administration (FDA). This meeting represents a key milestone in advancing cytisinicline’s development as a potential first-in-class treatment for nicotine e-cigarette or vaping cessation. Achieve obtained FDA agreement on the proposed single Phase 3 study design for cytisinicline treatment in vaping cessation and on the additional requirements for submitting a supplemental new drug application (sNDA) to expand cytisinicline for the treatment for vaping cessation. The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objective
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News
- Achieve Life Sciences Appoints Mark Oki as Chief Financial OfficerGlobeNewswire
- Achieve Life Sciences to Advance First Vaping Cessation Therapy After Successful End-of-Phase 2 Meeting with FDA [Yahoo! Finance]Yahoo! Finance
- Smoking Cessation Pipeline Insight 2024, with Focus on Emerging Drugs Cytisinicline (Achieve Life Sciences), EMB-001(Embera Pharmaceuticals) and SBP-9330 (Camino Pharma) [Yahoo! Finance]Yahoo! Finance
- Achieve Life Sciences, Inc. (NASDAQ: ACHV) was upgraded by analysts at RODMAN&RENSHAW to a "strong-buy" rating.MarketBeat
- Achieve Life Sciences Announces Participation at Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
ACHV
Earnings
- 11/7/24 - Miss
ACHV
Sec Filings
- 12/9/24 - Form 4
- 12/9/24 - Form 4
- 12/9/24 - Form 3
- ACHV's page on the SEC website