Achieve down on an FDA update

 

• 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.

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.

https://investorplace.com/2023/12/why-is-achieve-life-sciences-achv-stock-down-44-today/