04:02 AM EDT, 07/14/2025 (MT Newswires) -- Takeda Pharmaceutical ( TAK ) said Monday that two phase 3 studies of its investigational therapy oveporexton for the treatment of narcolepsy type 1 met all primary and secondary endpoints.
The two studies showed "statistically significant" and "clinically meaningful" improvement in wakefulness, daytime sleeping, cataplexy, ability to maintain attention, overall quality of life, and daily life functions, with patients "achieving near normal ranges across the broad range of symptoms investigated," the company said.
Takeda said it intends to submit a new drug application with the US Food and Drug Administration and other worldwide regulatory authorities in fiscal 2025.