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Axsome Stock Tanks 20% As The Co. Expects FDA's CRL For AXS-07 For Acute Treatment Of Migraine

Shares of Axsome Therapeutics, Inc. (AXSM) slipped over 20% on Monday morning after the company said it expects the U.S. Food and Drug Administration to decline approval for its acute treatment of migraine.

AXSM is currently trading at $31.12, down $7.98 or 20.41%, on a volume of 1.8 million shares, above average volume of 900 thousand. The stock had opened its trading at $30.40 after closing Friday's trading at $39.10. The shares have traded between $19.38 and $74.10 in the 52 week period.

In an SEC Filing, Axsome said that on April 22 the company was informed by the FDA that chemistry, manufacturing, and controls issues identified during the regulator's review of the company's New Drug Application for its AXS-07 product candidate for the acute treatment of migraine are unresolved.

The company said it expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.

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