Why Is Achieve Life Sciences (ACHV) Stock Down 44% Today?


  • Achieve Life Sciences (ACHV) stock is down alongside an update from the FDA.
  • The agency is seeking more information for the company’s cytisinicline NDA.
  • This could delay the company’s submission time for the drug candidate.
ACHV Stock - Why Is Achieve Life Sciences (ACHV) Stock Down 44% Today?

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Achieve Life Sciences (NASDAQ:ACHV) stock is dropping on Tuesday after the company provided an update on its New Drug Application (NDA) for cytisinicline.

A meeting with the Food and Drug Administration (FDA) saw the agency request additional data concerning cytisinicline before it will approve its NDA. This has it seeking long-term exposure data beyond 12 weeks to ensure the safety profile of the drug candidate.

Achieve Life Sciences notes that it’s contacting the FDA for more details about the data it wants. That means its NDA filing for cytisinicline could be delayed as it looks to obtain that information. The company says it will provide investors with an update on its NDA plans in the first quarter of 2024.

What This Means for ACHV Stock

With this news, Achieve Life Sciences is dealing with the fact that it may take longer to submit its NDA for cytisinicline than previously expected. Considering that also delays when it can start making money from the drug, it makes sense this would have a negative effect on ACHV stock today.

As of this writing, ACHV stock is down 44%, with some 866,400 shares traded. Its daily average trading volume is about 35,000 shares.

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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

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