Achieve Life Sciences: FDA requires long-term safety data; NDA filing likely delayed

ACHIEVE LIFE SCIENCES, INC.

FDA supports NDA on two Phase 3 trials but demands long-term safety data beyond 12 weeks for chronic-use label.
Company expects further FDA input in Q1 2024; NDA submission timing may be delayed.
Long-term safety data may be collected from cumulative treatment and vaping cessation program.
Single drug candidate cytisinicline at risk; delay could impact regulatory timeline.

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