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FDA Accepts Axsome's NDA For AXS-12 In Narcolepsy-Related Cataplexy

AXSM
Healthcare & BiotechRegulation & LegislationCompany Fundamentals

Axsome Therapeutics said the FDA accepted its New Drug Application for AXS-12 (reboxetine) for treating cataplexy in patients with narcolepsy. The acceptance is a positive regulatory milestone but does not by itself confirm approval or timing.

Analysis

Axsome Therapeutics said the FDA accepted its New Drug Application for AXS-12 (reboxetine) for treating cataplexy in patients with narcolepsy. The acceptance is a positive regulatory milestone but does not by itself confirm approval or timing.

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