#TakedaPharmaceutical

Takeda Pharmaceutical announces that the U.S. FDA has accepted the new drug application for rusfertide, co-developed with Protagonist Therapeutics, and granted it priority review designation. The target date for review completion is Q3 2026.

Takeda Pharmaceutical has announced that the FDA has accepted the new drug application for oveporexton, a treatment for narcolepsy type 1, and designated it for priority review. The target date for review completion is Q3 2026.

For Q3 of fiscal year ending March 2026, consolidated revenue was 3,411.2 billion yen (3.3% YoY decrease), operating income was 422.4 billion yen (1.2% YoY increase), and quarterly profit was 216.3 billion yen (2.4% YoY increase), leading to an upward revision of full-year earnings guidance.

In the Phase 3 clinical trial of Zasositinib, the primary endpoints were achieved at week 16, with more than half of patients reaching PASI 90 and approximately 30% achieving PASI 100 indicating complete clearance of skin lesions. Safety profile was favorable.

Zasositinib (TAK-279) achieved primary endpoints in a Phase 3 clinical trial targeting patients with moderate to severe plaque psoriasis, with over half achieving PASI90 and approximately 30% achieving PASI100 at week 16.

Takeda Pharmaceutical Company Limited, in collaboration with Protagonist Therapeutics, announced 52-week data from the Phase 3 VERIFY trial of rusfertide in patients with polycythemia vera, demonstrating sustained hematocrit control and safety.