Takeda Q1FY26 Results: Core revenue falls 0.5% at constant exchange rates

Core revenue declined 0.5% at constant exchange rates to 1.22 trillion yen in Q1FY26. Core operating profit fell 0.5% at constant exchange rates, aligning with management expectations. New launches grew 22.6% at constant exchange rates, contributing 4% of total revenue. Takeda secured exclusive global rights to Rusfertide after Protagonist opted out of co-promotion. Orzafl received first approval in China, with U.S. and Japan launches expected in H2 2026.

FDA accepts Takeda zasocitinib NDA for psoriasis under priority review

US FDA accepts Takeda's zasocitinib NDA for moderate-to-severe plaque psoriasis. Agency designates submission for Priority Review with PDUFA date in Q1 2027. EMA also accepts marketing authorization application for review. Phase 3 data shows 71% sPGA 0/1 response in primary study at week 16.

Takeda wins FDA approval for MIMRYLO, triggers $275m payout to Protagonist

FDA approves Takeda's MIMRYLO for polycythemia vera based on Phase 3 VERIFY study data. Approval triggers $275 million in payments to partner Protagonist Therapeutics. Trial showed 76.9% clinical response rate in maintaining hematocrit below 45%. Protagonist eligible for up to $875 million in additional milestones and tiered royalties. Takeda maintains FY26 financial outlook despite the regulatory milestone.

Takeda secures Japan approval for ORZEYFUL, first holistic NT1 treatment

Takeda secures Japanese MHLW approval for ORZEYFUL (oveporexton) for adult NT1 treatment. ORZEYFUL is the first-in-class oral orexin receptor 2 agonist to treat NT1 holistically. Approval follows Phase 3 FirstLight and RadiantLight studies showing significant symptom improvement. This marks the third global regulatory approval for the drug, after China and the US. US controlled substance classification remains under review by the DEA.

Takeda secures $5.6B US VA contract for drugs and biologicals through 2031

Takeda Pharmaceutical Company Limited won a $5.6 billion indefinite-delivery contract from the US Department of Veterans Affairs. The deal covers the supply of drugs and biologicals and is valid through 2031. This award secures long-term supply chain integration for Takeda within the US veteran healthcare system.

FDA approves Takeda's ORZEYFUL as first drug to treat narcolepsy type 1 cause

FDA approves Takeda's ORZEYFUL as the first drug to treat the underlying cause of narcolepsy type 1 in adults. The oral orexin receptor 2 agonist targets orexin deficiency, shifting treatment from symptom management to holistic care. Commercial launch awaits DEA scheduling.