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Protagonist Announces Presentation of One-Year Phase 3 Data for ICOTYDE(TM) in Moderate-to-Severe Plaque Psoriasis at the 2026 American Academy of Dermatology (AAD) Annual Meeting
28.03.2026

Protagonist Announces Presentation of One-Year Phase 3 Data for ICOTYDE(TM) in Moderate-to-Severe Plaque Psoriasis at the 2026 American Academy of Dermatology (AAD) Annual Meeting

One-year Phase 3 data for ICOTYDE to be presented at AAD 2026 demonstrate lasting skin clearance and a favorable safety profile in a once daily pill for moderate-to-severe plaque psoriasis Results further support the differentiated profile of ICOTYDE, the first and only IL-23 receptor targeted oral peptide NEWARK, CA / ACCESS Newswire / March 28, 2026 / Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") today announced new one-year Phase 3 results for ICOTYDE™ (icotrokinra) were presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further support the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis.

Protagonist Therapeutics Announces U.S. FDA Approval of ICOTYDE(TM) (icotrokinra) for the Treatment of Moderate to Severe Plaque Psoriasis
18.03.2026

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 pill Approval 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 payments Webcast 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.

Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera
02.03.2026

Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera

OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act.

CORRECTION: Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
25.02.2026

CORRECTION: Protagonist Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.) NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expected by mid-2026 Pre-clinical pipeline expanded with novel wholly-owned candidates PN-477, an oral and s.c.