Why Is Smoking Cessation-Focused Achieve Life Sciences Stock Trading Lower Today?
Portfolio Pulse from Vandana Singh
Achieve Life Sciences Inc (NASDAQ:ACHV) stock dropped 41.6% after a pre-NDA meeting with the FDA regarding cytisinicline, a smoking cessation drug. The FDA indicated that long-term safety data beyond 12 weeks is required to assess the safety risk, suggesting that the NDA submission may be delayed. The company will update its NDA submission timing after further FDA input expected in Q1 of 2024.
December 12, 2023 | 5:36 pm
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NEGATIVE IMPACT
Achieve Life Sciences' stock fell sharply due to potential delays in the NDA submission for cytisinicline after the FDA requested additional long-term safety data.
The significant stock price drop reflects investor concerns over the potential delay in the NDA submission and the additional data requirements set by the FDA. This regulatory hurdle is critical as it directly impacts the company's ability to bring its product to market in a timely manner.
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IMPORTANCE 90
RELEVANCE 100