Company: TAK
Filing Date: 2025-07-14
Form Type: 6-K
Source: 0001395064-25-000117
Chunk: 2

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-07-14
Form: 6-K
Chunk 2
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y, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated.

Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study.

“We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. T he studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “ The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.”

Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration and additional global regulatory authorities in fiscal year 2025.

Results from the Phase 3 studies have no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026.

#### About Narcolepsy Type 1 (NT1) and Orexin Science
NT1 is a chronic, rare neurological disease that results in a range of debilitating symptoms including excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking. Additionally, individuals living with NT1 often report cognitive symptoms, including difficulty thinking clearly, remembering, concentrating and paying attention. NT1 is caused by loss of the orexin-producing neurons in the brain, which regulate wakefulness and sleep, and is also believed to be essential to other functions such as attention through activation of orexin receptors. Currently, the standard of care is limited to symptomatic therapies that may only partially address some of the symptoms people face.

#### About Oveporex