Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission [Yahoo! Finance]
Achieve Life Sciences, Inc. - Common Shares (ACHV)
Last achieve life sciences, inc. - common shares earnings: 3/13 08:00 am
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Source: Yahoo! Finance
SEATTLE and VANCOUVER, British Columbia, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the adequacy and timing of long-term cytisinicline exposure data requirements for a New Drug Application (NDA). During pre-NDA discussions held in the fourth quarter of 2023, the FDA expressed support for an NDA submission based on adequate data to assess for efficacy from the two completed randomized and controlled Phase 3 trials, ORCA-2 and ORCA-3. In addition, the FDA advised that long-term exposure data to assess for safety beyond 12 weeks would be needed to adequately evaluate safety risks given that the FDA views smoking cessation drugs as products for chronic, repeat, or intermittent use as patients may rel
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News
- Achieve Life Sciences to Announce First Quarter Financial Results and Host Conference Call and Webcast on May 9, 2024GlobeNewswire
- Achieve Life Sciences, Inc. (NASDAQ: ACHV) is now covered by analysts at Jonestrading. They set a "buy" rating and a $20.00 price target on the stock.MarketBeat
- Smoking Cessation and Nicotine Deaddiction Landscape Report 2024: Therapeutic Assessment of Novel Drug Candidates, Emerging Drugs and the Route to Commercialization [Yahoo! Finance]Yahoo! Finance
- Nicotine Addiction Drug Pipeline Report 2024: Comprehensive Insights on 15+ Companies and 15+ Pipeline Drugs [Yahoo! Finance]Yahoo! Finance
- Achieve Life Sciences to Present at Life Science Innovation Northwest 2024 ConferenceGlobeNewswire
ACHV
Earnings
- 3/28/24 - Beat
ACHV
Sec Filings
- 4/26/24 - Form S-3
- 4/26/24 - Form ARS
- 4/26/24 - Form DEF
- ACHV's page on the SEC website