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NASDAQ: PTGX Protagonist Therapeutics, Inc 8-K

PTGX books $50M ICOTYDE approval milestone, opts out of rusfertide profit-share for $200M

Filed May 5, 2026 · Period ending May 5, 2026 · ~2 min read

Key Changes

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    FDA approved ICOTYDE (icotrokinra) for moderate-to-severe plaque psoriasis in March 2026, triggering a $50M milestone from J&J; PTGX remains eligible for up to $580M in additional milestones plus 6–10% tiered royalties on global sales.

    Exhibit 99.1 verify on EDGAR →
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    PTGX exercised opt-out from U.S. profit-sharing on rusfertide (April 28), triggering $200M immediate payment plus $200M opt-out fee and $75M upon NDA approval; shifts economics to 14–29% worldwide royalties (21% weighted-average at $1.5B sales) and up to $775M in sales milestones.

    Exhibit 99.1 verify on EDGAR →
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    FDA granted Priority Review for rusfertide NDA (March 2) with PDUFA target date in August 2026; application supported by Phase 3 VERIFY and long-term Phase 2 data for polycythemia vera treatment.

    Exhibit 99.1 verify on EDGAR →

2 more material changes behind this preview — plus the full narrative summary, section-by-section diffs against the prior filing, and verbatim quotes with EDGAR citations.

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Generated by AI · Jun 24, 2026 12:18 AM