Full Press Release Details
MIMRYLO™ (rusfertide) Approved by FDA for the Treatment of Erythrocytosis in Adults with Polycythemia Vera; Approval Triggered $275 Million in Payments to Protagonist
Comprehensive Phase 2b Program with PN-881, an Oral IL-17 Antagonist for Psoriasis, Planned to Initiate in Early Q1 2027
$300 Million Share Repurchase Program Announced in September 2026
Cash, Cash Equivalents and Marketable Securities of $834.6 Million as of September 30, 2026
NEWARK, CA / ACCESS Newswire / November 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.
"The third quarter was a defining period for Protagonist, with FDA approval of MIMRYLO, our second approval this year for a first-in-class peptide drug, and the continued strong commercial launch of ICOTYDE under our collaboration with Johnson & Johnson," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "MIMRYLO reflects years of disciplined scientific dedication and clinical execution, and together with ICOTYDE, provides immensely important validation both of our innovative expertise in peptide therapeutics and of the successful pharma-biotech partnership model we have built around these two approved drugs. The partnerships are fueling an accelerating revenue engine, which provides the flexibility to fund the next generation of wholly owned programs emerging from our platform, and to return meaningful capital to shareholders through a share repurchase program."
Third Quarter 2026 Recent Developments and Upcoming Milestones
MIMRYLO™ (rusfertide): Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera
ICOTYDE® (Icotrokinra): Oral IL-23 Receptor Antagonist
Wholly-Owned Clinical and Discovery Programs
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 (IL-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.
More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com .
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the company's expectations related to future royalty and milestone payments pursuant to the Company's collaboration arrangements, the timing and results of our clinical development programs, and the level of our future development expenses. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.
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PROTAGONIST THERAPEUTICS, INC. Consolidated Statements of Operations (Amounts in thousands except share and per share data)
Stock-based Compensation (In thousands)
PROTAGONIST THERAPEUTICS, INC. Selected Consolidated Balance Sheet Data (In thousands)