AXS-12's clinical development program in narcolepsy includes three controlled efficacy trials, and a completed long-term safety trial. The drug has already been granted orphan drug designation, a ...

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

The biopharmaceutical company accepted for filing a supplemental new drug application for AXS-05 to treat Alzheimer's disease agitation, and has granted the application priority review designation, ...

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

Data suggest that pitolisant, a histamine 3-receptor antagonist/inverse agonist under development for narcolepsy treatment, showed limited abuse potential and other benefits, according to findings ...

Michael Thorpy, MD, director, Sleep-Wake Disorders Center, Montefiore, and professor of neurology, Albert Einstein College of Medicine, addresses the treatment of narcolepsy in recent years. There are ...

The narcolepsy treatment market presents opportunities through increased awareness, R&D investments, and improved diagnostics ...

Credit: Getty Images. Harmony Biosciences announced that the Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for pitolisant for the treatment of ...

Narcolepsy with cataplexy, now known as type 1 narcolepsy, is a chronic neurological disorder that affects a person’s sleep-wake cycle and involves muscle weakness. The condition can cause a person to ...

As a sleep specialist, I find it incredibly rewarding to treat people with narcolepsy. It can be unnerving to be diagnosed with the disorder. But it’s also a huge relief, because people finally know ...

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 ...