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Positive regulatory milestone in Japan expands addressable market and validates the orexin program; coupled with existing approvals elsewhere, it underpins potential near-term revenue uplift and franchise value, though US timing remains contingent on DEA scheduling.
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Takeda announced MHLW approval of ORZEYFUL (oveporexton) for adult narcolepsy type 1 in Japan, a first-in-class oral OX2R agonist. Phase 3 results demonstrated broad NT1 symptom improvements, underpinning a third global approval alongside China and the US (DEA scheduling under review). Launch preparations are underway, with potential meaningful near-term revenue and pipeline validation.
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