Company: TAK
Filing Date: 2025-10-30
Form Type: 6-K
Source: 0001395064-25-000154
Chunk: 22

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-10-30
Form: 6-K
Chunk 22
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 the New England Journal of Medicine published data from Phase 2b trial (TAK-861-2001) of oveporexton in people with Narcolepsy Type 1 (NT1). The primary and secondary endpoints from the study assessed the impact of oveporexton across objective and subjective measures of wakefulness and daytime sleepiness, cataplexy rates and safety compared to placebo. Results demonstrated significant improvement in excessive daytime

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Translation for reference purpose only

sleepiness (EDS), reductions in cataplexy events and clinically meaningful improvements in disease severity and quality of life across all doses tested compared to placebo through eight weeks of treatment. The study also indicated that oveporexton was generally safe and well tolerated.

– In September 2025, Takeda presented orexin data from the landmark oveporexton Phase 3 program in NT1, during multiple oral presentations at the World Sleep 2025 Congress. Both the FirstLight and the RadiantLight studies met all primary and secondary endpoints demonstrating statistically significant and clinically meaningful improvement across a broad range of NT1 symptoms compared to placebo with p-values of <0.001 across all doses (twice-daily 1mg/twice-daily 2mg) at week 12. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study. The oral presentations at World Sleep included data from objective and patient-reported measures of wakefulness, cataplexy, symptom severity and quality of life. Takeda plans to submit a New Drug Application with the U.S. Food and Drug Administration (FDA) and additional global regulatory authorities in fiscal year 2025.

– Wakefulness: Oveporexton improved excessive daytime sleepiness demonstrating statistically significant improvement from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT) and in Epworth Sleepiness Scale (ESS) scores at week 12 across doses compared to placebo. The majority of participants treated with the 2/2mg dose achieved wakefulness within normative range (≥20 min) on the MWT, and close to 85 percent of participants achieved ESS scores comparable to healthy individuals (≤10).

– Cataplexy: Oveporexton demonstrated significant reduction