Protagonist Therapeutics

FDA approval of MIMRYLO (rusfertide) triggered $275 million in payments to Protagonist Therapeutics (a $200M opt-out fee plus a $75M approval milestone). Under the April opt-out, Protagonist agreed to tiered royalties of 14%–29% on worldwide net sales and remains eligible for up to $875 million of additional milestones, while Takeda assumes global development and commercialization. The Phase 3 VERIFY trial showed 76.9% response with MIMRYLO plus standard care versus 32.9% for placebo, but Protagonist relinquishes pricing and launch control and relies on Takeda for market access. The royalty deal provides non-dilutive capital and lower execution risk but limits upside compared with a retained profit share and depends on broad payer and physician adoption. » Plus sur finance.yahoo.com

The FDA has approved MIMRYLO (Rusfertide) for treatment of erythrocytosis in adults with polycythemia vera, allowing Takeda to commercialize the drug and triggering immediate payments of $275 million to Protagonist (a $200 million opt‑out plus a $75 million approval milestone). Protagonist can also receive up to $875 million in additional milestones and tiered royalties of 14–29% on worldwide net sales. Approval was based on the phase 3 VERIFY study, in which 76.9% of patients treated with MIMRYLO achieved a clinical response versus 32.9% in the placebo group. The most common adverse events were injection‑site reactions (56%) and anemia (16%); treatment is administered weekly by subcutaneous injection. » Plus sur de.investing.com

Shares of Protagonist Therapeutics rose to a new all-time high of $155.01, giving it a market capitalization of about $10 billion after gaining 175.66% last year. For Q2 2026 the company reported GAAP earnings per share of $2.29 and license and collaboration revenue of $213 million, of which $200 million came from a Takeda opt-out payment. Several analysts raised their ratings and price targets (including Goldman Sachs $186, Citizens $165), while InvestingPro rates the stock as overvalued relative to fair value. » Plus sur de.investing.com