The Latest Breaking News from Axsome

With a strong pipeline, these two biotechs are poised for explosive growth.

RBC flags this biopharma stock as recession-ready, with stellar upside potential hiding in plain sight.

Axsome Therapeutics Inc (NASDAQ: AXSM) shares rallied 40% on Monday morning after the company received some positive news from the U.S. Food and Drug Administration regarding its AXS-05 novel treatment for MDD (depression).

The FDA has issued a Complete Response Letter (CRL) to Axsome Therapeutics Inc's (NASDAQ:AXSM) AXS-07 for the acute treatment of migraine.  The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval…

The FDA has informed that Axsome Therapeutics Inc (NASDAQ:AXSM) chemistry, manufacturing, and controls issues identified during the review of AXS-07 remain unresolved. The Company is seeking approval for AXS-07 for the acute treatment of migraine.  Based on the time remaining in the review cycle, the Company expects to receive a Complete Response Letter…

Axsome Therapeutics Inc (NASDAQ: AXSM) shares are trading higher Tuesday after the company announced it received and agreed to Postmarketing Requirements/Commitments proposed by the U.S. Food and Drug Administration with respect to the New Drug Application (NDA) for its AXS-05.

Axsome Therapeutics Inc (NASDAQ: AXSM) is trading higher Monday morning after the company announced it will acquire Sunosi from Jazz Therapeutics PLC (NASDAQ: JAZZ).

Here's a roundup of top developments in the biotech space over the last 24 hours:

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