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PTGX-News
PTGX-Events
Protagonist Partners with Takeda to Launch MIMRYLO
Protagonist Therapeutics (PTGX) announced that Takeda (TAK) received U.S. Food and Drug Administration, FDA, approval for MIMRYLO, a subcutaneously delivered first-in-class hepcidin mimetic peptide for the treatment of erythrocytosis in adults with polycythemia vera. MIMRYLO will be commercialized by Takeda under the worldwide license and collaboration agreement entered into in 2024 between Protagonist and Takeda.
Protagonist Reports Q2 Revenue of $213.48M, Below Consensus
Reports Q2 revenue $213.48M, consensus $223.17M. "The second quarter of 2026 marked a defining growth phase for Protagonist with a successful commercial launch of ICOTYDE through our strategic partner and accelerating momentum across our internal R&D pipeline. ICOTYDE is quickly becoming a paradigm-shifting oral therapy for patients with moderate-to-severe plaque psoriasis, and rusfertide is approaching an FDA decision that could establish it as a first-in-class erythrocytosis targeted medicine for patients with polycythemia vera," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "Equally exciting is the decision to advance our wholly owned oral IL-17 antagonist PN-881 into a comprehensive Phase 2b psoriasis program, based on the strongly supportive pharmacokinetic results from the Phase 1 study. Behind PN-881, we have a maturing set of diverse assets moving toward clinical studies in obesity, hematology and immunology. These are the results of years of disciplined investment in differentiated science and mark the beginning, not the culmination, of a new phase of value creation as we continue to advance our peptide platform and clinical pipeline."
Protagonist Reports Q1 Revenue of $56.37M, Exceeding Expectations
Reports Q1 revenue $56.37M, consensus $16.27M. License and collaboration revenue of $56.4M consisted of a $50M milestone earned from FDA approval of Icotyde. "The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide, and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477," said Dinesh V. Patel, the Company's President and Chief Executive Officer. "These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time."
Protagonist Therapeutics Exercises Opt-Out Right for $400 Million
Protagonist Therapeutics (PTGX) announced that it has exercised its right to opt out of the 50:50 U.S. profit and loss sharing arrangement under its worldwide license and collaboration agreement with Takeda (TAK) for rusfertide, an investigational first-in-class hepcidin mimetic peptide under U.S. Food and Drug Administration, FDA, Priority Review for the treatment of adults with polycythemia vera. By exercising its opt-out right during the contractual opt-out period, Protagonist becomes eligible to receive up to $400 million in opt-out payments, consisting of $200 million payable upon the opt-out election and a further $200 million payable upon FDA approval of rusfertide for the treatment of adults with PV. In addition, U.S. approval of rusfertide would trigger a $75 million milestone payment, bringing total potential cash payable in connection with the opt-out election and U.S. approval to $475 million.
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