Icotrokinra Hydrochloride

MIMRYLO™ is the First and Only Hepcidin Mimetic Peptide Therapy Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera, Offering a Novel Mechanism to Maintain Hematocrit Control, Meaningfully Reduce Phlebotomy Burden, and Improve Fatigue Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Response During Weeks 20-32 FDA Approval Triggers $275M in Milestones, 14%-29% Royalties, with Up to an Additional $875M in Potential Future Milestones Investor call to be held Monday, August 31st at 8:30 am ET August 28, 2026 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") announced today that Takeda received U.S. Food and Drug Administration (FDA) approval for MIMRYLO (rusfertide), a subcutaneously delivered first-in-class hepcidin mimetic peptide for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is the first and only hepcidin mimetic approved for polycythemia vera (PV), a blood cancer characterized by excessive production of red blood cells. "Today's FDA approval of MIMRYLO represents a paradigm shifting approach to management of PV. MIMRYLO mimics the action of hepcidin, the body's natural master regulator of iron availability thereby controlling hematocrit levels and helping restore iron balance. MIMRYLO was conceived fourteen years ago with the idea that a mimetic of hepcidin, the body's primary regulator of iron homeostasis, could address the underlying biology of erythrocytosis in PV. The approved label also reflects improvement in fatigue as measured by PROMIS Fatigue Short Form 8a." said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "I am very proud of what the team at Protagonist, in partnership with investigators and patients, have accomplished in bringing this drug over the finish line, and we have full confidence in Takeda as the ideal partner to bring MIMRYLO to patients who need it most." "This is Protagonist's second FDA approval in 2026, reflecting years of disciplined investment in the right type of innovative projects, and working with the right partners at the right time," Patel continued. "With two approved products validating our peptide-centric drug discovery and development acumen and a strong financial foundation, the Company is now focused on leveraging its expertise to advance the next generation of wholly owned product candidates in IL-17, obesity, and beyond with the intent of addressing unmet needs of patients and creating long-term value for our shareholders." MIMRYLO will be commercialized by Takeda under the worldwide license and collaboration agreement entered into in 2024 between Protagonist and Takeda. Protagonist discovered rusfertide (PTG-300) and had primary responsibility for its development through Phase 3, with Takeda assuming responsibility for NDA submission and commercialization following Protagonist's opt-out election in April 2026. FDA approval of MIMRYLO triggers $275 million in payments to Protagonist, consisting of a $200 million opt-out fee and a separate $75 million approval milestone. Protagonist is eligible to receive up to an additional $875 million in total potential milestone payments, as well as tiered royalties ranging from 14% to 29% on worldwide net sales, corresponding to approximately 21% on a weighted-average basis at $1.5 billion in annual sales. Clinical evidence summary MIMRYLO was approved on the basis of the Phase 3 VERIFY study, a randomized, double-blind, placebo-controlled trial in patients with polycythemia vera. In VERIFY, patients in the MIMRYLO arm achieved statistically significant benefit over the placebo arm, including the proportion of responders (with absence of phlebotomy eligibility), mean number of phlebotomies, proportion of participants maintaining hematocrit 15%) adverse reactions were injection site reactions (56%) and anemia (16%). PV is characterized by the excessive production of red blood cells (erythrocytosis), leading to elevated hematocrit which can increase blood viscosity, or thickness. This has the potential to result in life-threatening thrombotic events, including stroke, deep vein thrombosis and pulmonary embolism. Patients with PV may also experience burdensome symptoms, including severe fatigue, pruritus (itching), difficulty concentrating and night sweats. Patients with PV experiencing uncontrolled hematocrit have a four times higher risk of cardiovascular death or major cardiovascular events compared to patients who achieve a hematocrit of less than 45%1. An estimated 78% of patients still experience uncontrolled hematocrit with current standard of care, including phlebotomy and cytoreductive therapies. MIMRYLO is the first and only hepcidin mimetic peptide approved for the treatment of erythrocytosis in adults with polycythemia vera (PV). Rusfertide mimics the action of the natural hormone hepcidin, the body's natural master regulator of iron availability, suppressing red blood cell production by reducing iron availability to erythroid progenitor cells, thereby controlling hematocrit levels. Unlike current standards of care, which include phlebotomy and cytoreductive therapy and do not address the mechanism of iron dysregulation in PV, MIMRYLO directly targets red blood cell overproduction in PV. In the Phase 3 VERIFY study, 76.9% of patients receiving MIMRYLO plus current standard of care achieved a clinical response during Weeks 20-32, compared with 32.9% of patients receiving placebo plus current standard of care. The study also demonstrated improvement in fatigue as measured by PROMIS Fatigue Short Form 8a. For patients who have spent years managing a chronic, burdensome disease through frequent blood draws and ongoing cytoreductive therapy, MIMRYLO represents a fundamentally different approach, leveraging the body's natural regulatory systems to control hematocrit and help restore iron balance. MIMRYLO is self-administered as a weekly subcutaneous injection. MIMRYLO is currently approved in the U.S. for the treatment of erythrocytosis in adults with PV. Protagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further clinical and regulatory development and commercialization. Protagonist also discovered and led research and development through Phase 3 for MIMRYLO™ (rusfertide), a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceutical Company Limited for worldwide commercialization. MIMRYLO is approved in the U.S. for the treatment of erythrocytosis in adults with PV. The Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs. 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