FDA Approval of MIMRYLO Triggers $275M Payments for Protagonist
The U.S. Food and Drug Administration approved rusfertide (brand name MIMRYLO) from Takeda Pharmaceutical Company Limited, triggering a total of $275 million in payments to Protagonist Therapeutics Inc. (NASDAQ:PTGX). The payment includes an additional $200 million opt-out fee and a separate $75 million approval milestone. Instead of maintaining the original 50:50 U.S. profit-and-loss arrangement with Takeda, Protagonist opted for tiered royalties ranging from 14% to 29% on worldwide net sales. This decision allows Protagonist to retain a high royalty share and access non-dilutive capital while shifting commercial control of MIMRYLO to Takeda. The approval adds to the $849.5 million in cash, equivalents, and marketable securities reported by PTGX as of June 30, with potential for up to an additional $875 million from future milestones tied to international approvals or sales thresholds. The Phase 3 VERIFY trial showed strong efficacy results: 76.9% of patients receiving MIMRYLO plus standard care achieved the primary response endpoint compared to 32.9% with placebo, indicating significant potential for market adoption.
Topics: drug approval milestone payments pharmaceuticals royalty agreements