Source disclosure: February 10, 2026
Takeda Pharmaceutical Company Limited [4502.T]
TOKYO, Feb 10 (Pulse News Wire) – Takeda Pharmaceutical Company Limited (4502.T) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for oveporexton (TAK-861) targeting narcolepsy type 1 (NT1).
The FDA also granted priority review status, setting a Prescription Drug User Fee Act (PDUFA) action date for the third quarter of 2026 (July-September 2026). Oveporexton is designed to address the deficiency in orexin signaling responsible for NT1, a chronic and rare neurological disorder characterized by excessive daytime sleepiness and cataplexy.
The NDA submission is based on comprehensive data from global Phase 3 clinical trials, including FirstLight (TAK-861-3,001) and RadiantLight (TAK-861-3,002). Results showed statistically significant and clinically meaningful improvements across key endpoints such as wakefulness, excessive daytime sleepiness, cataplexy, sustained attention, quality of life, and daily functioning.
Andrew Plump, President of Research and Development at Takeda, stated, “This milestone brings us closer to potentially transforming the treatment paradigm for NT1 patients who currently face unmet medical needs.” The impact of this application on Takeda’s fiscal year 2025 consolidated earnings forecast is expected to be minor.
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