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Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis
ICOTYDE is the first and only IL-23R targeted oral peptide that delivers complete skin clearance and a favorable safety profile in a once-daily pillApproval
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"ICOTYDE is the first and only IL-23R targeted oral peptide that delivers complete skin clearance and a favorable safety profile in a once-daily pillApproval supported by four phase 3 studies that met all primary endpoints and demonstrated a favorable safety profile in 2,500 patients$50 million milestone payment triggered by FDA approval; Protagonist is eligible to receive 6 - 10% royalties on sales and up to $580 million in future milestone paymentsWebcast and conference call to be held at 8:30 am ET on March 18 NEWARK, CA / ACCESS Newswire / March 18, 2026 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) (\"Protagonist\" or \"the Company\") announced today that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval for ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.ICOTYDE will be commercialized by Johnson & Johnson under the license and collaboration agreement established in 2017 between Protagonist and Janssen Biotech, Inc., a Johnson & Johnson company. 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 development and commercialization.FDA approval of ICOTYDE triggers a $50 million milestone payment to Protagonist. Protagonist is eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales, corresponding to 7.25% on a weighted-average basis at $4 billion in annual sales, with the top royalty tier of 10% applying to sales above $4 billion.\"ICOTYDE offers a novel plaque psoriasis treatment that combines the established efficacy and safety of IL-23 pathway blockade with the convenience of a once-daily oral pill. The FDA approval of ICOTYDE reflects a successful culmination of years of groundbreaking research and clinical development that began over 13 years ago in our laboratories and demonstrates the strength...