Takeda won FDA approval for Mimrylo (rusfertide) in polycythemia vera, with the engineered peptide originally developed by Protagonist Therapeutics. The approval follows a label broader than some analysts expected and opens a new, repeatable revenue opportunity for Takeda as parts of its pipeline shift toward hematology. The decision also marks a key milestone for Protagonist, which previously secured approvals earlier in the year. Under the partnership model, Takeda is positioned to commercialize Mimrylo across the adult PV population while Protagonist retains scientific momentum from a second approval cycle. Separately, FDA cleared Mimrylo specifically for erythrocytosis in adults with PV, confirming an anticipated weekly-injection regimen and reinforcing the therapy’s role as a targeted hepcidin-mimetic approach in a disease area with limited options.