Axsome’s AXS-14 Gets Regulatory Setback with RTF, says Morgan Stanley

Axsome Therapeutics, Inc. (NASDAQ:AXSM) is one of the 13 Biotech Stocks with Huge Upside Potential. The FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine has issued a Refusal to File letter for Axsome Therapeutics, Inc. (NASDAQ:AXSM) AXS-14 new drug application.

Is Axsome Therapeutics, Inc. (AXSM) the Best Performing Growth Stock in 2025?

A pharmacist preparing a prescription for a rapidly absorbed multi-mechanistic medicine.

The submission was deemed incomplete by the agency due to the use of an 8-week primary endpoint in one of the two supporting trials and a flexible-dose schedule. Vikram Purohit, an analyst at Morgan Stanley, stated that Axsome Therapeutics, Inc. (NASDAQ:AXSM) intends to start a fresh 12-week primary endpoint trial with a fixed dose in Q4. The stock is still rated as overweight by Morgan Stanley, which has set a price target of $190.

AXS-14’s regulatory setback is viewed as a temporary setback. The regulatory development of AXS-05 for Alzheimer’s disease agitation and the commercial success of Auvelity in major depressive disorder are seen by Morgan Stanley as Axsome Therapeutics, Inc. (NASDAQ:AXSM)’s primary 2025 value drivers.

The company is nevertheless optimistic about Axsome Therapeutics, Inc. (NASDAQ:AXSM)’s overall pipeline momentum and prospects for near-term revenue growth despite the AXS-14 filing struggle.

Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a biopharmaceutical business in the clinical stage. It is involved in the development of new treatments for conditions of the central nervous system or CNS, for which there are few available options. The business is among the stocks with the biggest upside.

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