FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton as a Potential First-in-Class Therapy ...

The FDA has accepted the New Drug Application for Priority Review for oveporexton in the treatment of narcolepsy type 1.

US FDA accepts and grants priority review status to Takeda’s oveporexton for the treatment of narcolepsy type 1: Osaka, Japan Wednesday, February 11, 2026, 12:00 Hrs [IST] Taked ...

The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) and granted Priority Review for ...

Alixorexton at all doses demonstrated significant improvements from baseline in mean sleep latency compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy ...

The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year. The acceptance of the new drug application (NDA) ...

CHICAGO -- Novel orexin receptor 2 agonist oveporexton normalized wakefulness for most people with narcolepsy type 1 in two randomized phase III trials. Mean sleep latency across four, 40-minute ...

– Alixorexton Demonstrated Clinically Meaningful and Statistically Significant Improvements in Wakefulness at All Doses Tested Compared to Placebo in Patients With Narcolepsy Type 1 – – Alixorexton ...

(RTTNews) - Alkermes plc (ALKS), a biopharmaceutical company, on Tuesday reported that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Alixorexton for the ...

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 ...