5 January 2026 - NDA includes 52 week data from Phase 3 VERIFY study, which met the primary and all four key secondary endpoints, showing rusfertide provided durable and sustained hematocrit control and improved pre-specified patient reported outcome measures.

Takeda and Protagonist Therapeutics announced the submission of a new drug application to the US FDA seeking approval of rusfertide for the treatment of adults with polycythemia vera.

Read Takeda press release