The FDA accepted the NDA for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy, setting a PDUFA target action date of May 1, 2027.

Axsome Therapeutics' new drug application for AXS-12 for the treatment of cataplexy in narcolepsy has been accepted by the U.S. Food and Drug Administration. The biopharmaceutical company said ...

FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc.

Axsome Therapeutics AXSM announced that the FDA has accepted the company’s new drug application (NDA) seeking approval for ...

Narcolepsy, with or without cataplexy, can have a substantial detrimental effect on well-being and quality of life. Because there is no cure for this condition, current treatments aim to improve ...

What Is Wakix, and Why Does It Matter? Wakix (pitolisant) is a prescription medication used to treat narcolepsy, a long-term neurological sleep disorder that causes excessive daytime sleepiness and, ...

DUBLIN--(BUSINESS WIRE)-- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of ...

Harmony Biosciences posts preliminary Q2 2026 Wakix revenues of about $261M, up 30% year over year, while reaffirming ...

Avadel Pharmaceuticals plc has published six manuscripts in a CNS Drugs supplement titled "A New Dawn in the Management of Narcolepsy," focusing on clinical management strategies, shared ...

Shares of NLS Pharmaceutics Ltd. NLSP gained 12% premarket on Monday after the Swiss clinical-stage biopharma company said it would proceed with phase 3 clinical studies of Mazindol ER, a treatment ...

Narcolepsy is a chronic neurological disorder characterised by excessive daytime sleepiness and, in type 1 cases, cataplexy resulting from selective loss of hypothalamic hypocretin (orexin) neurons.

Although sometimes portrayed in film and television as simply "falling asleep without warning," the reality of narcolepsy is far more complex.