Takeda Pharmaceutical Company Limited (TAK), a pharmaceutical company, on Monday reported new data from the Phase 3 FirstLight and RadiantLight trials for Oveporexton in treating Type 1 Narcolepsy.
Narcolepsy is a disorder which causes extreme sleepiness during the day, as the patient may fall asleep suddenly in the middle of an sctivity. The type 1 form of narcolepsy may be accompanied by the sudden loss of muscle tone, known as cataplexy, prior to falling asleep. There is currently no approved cure for narcolepsy.
Oveporexton (TAK-861) is an oral selective agonist of the orexin receptor 2 (OXR2), which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). The drug promotes wakefulness, reduces abnormal repeated eye movement (REM) sleep phenomena and decreases cataplexy.
The Phase 3 FirstLight and RadiantLight tirals were global, multicentre, placebo-controlled studies conducted with 168 and 105 patients respectively. Of those enrolled, more than 95% patients volunteered to continue in the ongoing long-term extension (LTE) study.
The released new data indicates that patients on various doses of oveporexton showed significant improvements in daily functioning by week 12. This was measured in six domains of the Functional Impacts of Narcolepsy Instrument (FINI), which evaluates tiredness, cognitive functioning, cataplexy, social activities, everyday activities and everyday responsibilities.
Patients also showed improved cognitive symptoms, as measured on the FINI Cognitive Function domains. Over 70% of patients reported no cognitive difficulties after dosing, compared to only 15% in the placebo arm. Furthermore, dosed patients saw an improvement in the quality of nighttime sleep, and reduced disturbances in sleep from the baseline.
The FDA previously accepted the new drug application (NDA) for oveporexton in treating NT1 under a priority review, with a Prescription Drug User Fee Act (PDUFA) date set in the third quarter of this year. The company has also filed for regulatory approval in China and Japan.
TAK closed Monday at $15.77, down 0.88%. In the overnight market, shares are trading at $16.01, up 1.52%.
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