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Benzinga

Technology

Ragothaman Srinivasan

FDA Issues Complete Response Letter (CRL) to Axsome Therapeutics for AXS-07 In Acute Migraine

FDA AXSM Nasdaq

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Axsome Therapeutics, Inc. (NASDAQ:AXSM) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

The NDA is supported by results from Phase 3 MOMENTUM and INTERCEPT trials of AXS-07 in the acute treatment of migraine compared to placebo and active controls.

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One subscription that gives you access to news from hundreds of sites

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