Why Axsome Therapeutics Stock Rocketed Higher to End 2025

• Axsome conscionable received precedence reappraisal designation for its astir important drug.

• Auvelity is an oral medicine already approved for adults with large depressive upset (MDD).

• Auvelity income soared 69% successful Q3.

• 10 stocks we similar amended than Axsome Therapeutics ›

Axsome Therapeutics (NASDAQ: AXSM) shares soared to adjacent retired the year. The institution released 2 items of quality today. Investors spot 1 successful peculiar arsenic a meaningful catalyst for the biopharmaceutical institution that specializes successful processing therapies for the absorption of slump and different neurological conditions.

Axsome shares rocketed much than 20% higher, and remained up by 19.4% arsenic of 12:10 p.m. ET.

Axsome announced contiguous that the U.S. Food and Drug Administration (FDA) granted precedence reappraisal designation for its AXS-05 cause for the attraction of Alzheimer's illness agitation. Axsome already has support for the medicine to dainty adults with large depressive upset (MDD). Branded arsenic Auvelity, income of the cause grew 69% year-over-year successful Q3 and accounted for 80% of Axsome's gross for the quarter.

The FDA has acceptable a people enactment day of April 30, 2026, giving investors a shortened timeline to spot a large imaginable catalyst for Axsome. CEO Herriot Tabuteau, MD, stated, "up to 76% of radical with Alzheimer's illness acquisition agitation, representing a important unmet aesculapian request for patients and their caregivers, and presently determination is simply a dearth of approved treatments."

AXS-05 was antecedently granted U.S. FDA Breakthrough Therapy designation for the attraction of Alzheimer's illness agitation successful June 2020. That gave investors a hint that it could beryllium a promising medicine, based connected preliminary objective evidence.

Now AXS-05 is starting to recognize that potential. Another cause successful Axsome's pipeline is AXS-12 for treating narcolepsy. Further affirmative quality was released contiguous with the work of FDA gathering minutes, indicating that Axsome's regulatory information bundle would beryllium acceptable for submission of a caller cause exertion (NDA) for AXS-12.

That submission is expected to hap adjacent month, providing investors with different imaginable catalyst for banal growth. Both items of bully quality person investors piling into Axsome banal connected the year's last time of trading.

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