Protagonist Therapeutics, Inc.

Protagonist Therapeutics Announces $300 Million Share Repurchase Program

Protagonist Therapeutics authorized a $300 million share repurchase program, to be funded by cash and royalties from its partnerships with Takeda and Johnson & Johnson. As of June 30, 2026, the company held $849.5 million in cash and marketable securities, excluding $275 million in upcoming payments from Takeda. The program is flexible and may be modified, suspended, or discontinued at any time, with no obligation to repurchase a specific number of shares.

•1mo ago

Protagonist Therapeutics Announces U.S. FDA Approval of Hepcidin Mimetic Peptide MIMRYLO(TM) (rusfertide) for Polycythemia Vera

Protagonist Therapeutics announced FDA approval of MIMRYLO (rusfertide), a first-in-class hepcidin mimetic peptide for treating erythrocytosis in adults with polycythemia vera. The approval triggers $275 million in payments to Protagonist, comprising a $200 million opt-out fee and a $75 million milestone, with potential for up to $875 million in additional milestones and tiered royalties of 14-29%. Takeda will handle global commercialization; Phase 3 VERIFY data showed 76.9% of patients achieved a clinical response during weeks 20-32 compared to 32.9% on placebo.

•2mo ago

Protagonist Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Protagonist swung to a profit in Q2 2026 with net income of $162.8 million, or $2.29 per diluted share, driven by $213.5 million in collaboration revenue largely from the Takeda partnership. The company enters the second half of the year with $849.5 million in cash as it approaches the August 2026 PDUFA decision date for rusfertide, a polycythemia vera treatment licensed to Takeda. Commercial partner Johnson & Johnson completed the first full quarter of ICOTYDE sales, while Protagonist advanced its pipeline by planning a Phase 2b study for oral IL-17 antagonist PN-881 and initiating a Phase 1 study for PN-477sc in obesity.

•2mo ago

Protagonist Therapeutics to Present Phase 3 VERIFY and Long-Term Rusfertide Data at the 2026 European Hematology Association Congress

Protagonist Therapeutics will present four abstracts on rusfertide at the 2026 European Hematology Association Congress in Stockholm. The presentations include subgroup efficacy and safety analyses from the pivotal Phase 3 VERIFY study, as well as long-term data from the Phase 2 REVIVE and THRIVE extension studies. The data covers outcomes in low-risk and high-risk polycythemia vera patients, including effects on cytoreductive therapy use, thromboembolic events, and patient-reported symptoms.

•5mo ago

Protagonist Reports First Quarter 2026 Financial Results and Provides Corporate Update

Protagonist reported Q1 revenue of $56.4 million, driven by a $50 million milestone payment triggered by the FDA approval of ICOTYDE for moderate-to-severe plaque psoriasis. The company swung to a profit of $0.06 per share compared to a loss in the prior year, bolstered by a cash position of $620.3 million that extends runway into 2028. In a major strategic shift, Protagonist exercised its opt-out right for rusfertide with partner Takeda, triggering an immediate $200 million payment and securing future economics of up to $75 million in approval milestones, $775 million in sales milestones, and tiered royalties of 14% to 29%. The FDA granted Priority Review to the rusfertide NDA with a PDUFA date in Q3 2026, while internal pipeline programs advanced with PN-881 Phase 1 completion expected mid-2026 and PN-477 Phase 1 initiation anticipated shortly after.

•5mo ago

Protagonist Exercises Rusfertide U.S. Opt-Out Right Under Takeda Collaboration

Protagonist Therapeutics exercised its opt-out right for rusfertide with partner Takeda, triggering an immediate $200M payment eligibility and shifting U.S. rights exclusively to Takeda. The move secures up to $475M in cash tied to the opt-out and potential FDA approval, plus tiered royalties of 14-29% on worldwide sales. Rusfertide remains under FDA Priority Review for polycythemia vera with a PDUFA date set for Q3 2026.

•6mo ago