The FDA has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1).

Alkermes wins FDA Breakthrough Therapy status for alixorexton in NT1 after Vibrance-1 data shows improvement in wakefulness.

Axsome stock jumps as the FDA grants priority review to sNDA for AXS-05 in Alzheimer's agitation, with a decision expected April 30, 2026.

New Drug Application (NDA) submission on track for January 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in ...

The latest update is out from Axsome Therapeutics ( (AXSM) ).

Axsome Therapeutics (AXSM) on Wednesday said it received formal pre–New Drug Application (NDA) meeting minutes from the U.S.

New Drug Application (NDA) submission on track for January 2026NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: ...

Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an NDA for AXS-12 for the treatment of cataplexy in narcolepsy. Axsome anticipates ...

Drivers with sleep conditions including sleep apnoea, narcolepsy and cataplexy must inform the DVLA or risk a fine of up to ...

Paul P. Doghramji, MD, discusses the underdiagnosis of narcolepsy especially among younger individuals and how clinicians can address this.

There are two forms of narcolepsy. In type 1, cataplexy is another symptom that involves sudden muscle weakness or paralysis. This symptom can occur suddenly and is usually when a person experiences ...