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Get filing alertsPTGX 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 view 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 view 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 view on EDGAR → -
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Q1 2026: revenue $56.4M (primarily ICOTYDE milestone), net income $3.8M ($0.06/share), cash $620.3M (down from $646.0M at year-end 2025), runway through at least 2028.
Item 2.02 verify on EDGAR → -
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Wholly-owned pipeline advancing: PN-881 (oral IL-17 antagonist) Phase 1 completion mid-2026, Phase 2 initiation by year-end; PN-477 (triple GLP/GIP/GCG agonist) Phase 1 for subcutaneous formulation mid-2026, oral formulation Q1 2027.
Exhibit 99.1 view on EDGAR →
Summary
Protagonist Therapeutics reported a transformative quarter driven by two partnered-asset milestones. In March, the FDA approved ICOTYDE (icotrokinra), an oral IL-23 antagonist for moderate-to-severe plaque psoriasis developed with Johnson & Johnson, triggering a $50 million milestone payment.
The approval validates Protagonist's oral peptide platform and leaves the company eligible for up to $580 million in additional regulatory and sales milestones plus 6–10% tiered royalties on global sales. Separately, the FDA accepted the rusfertide NDA with Priority Review in early March, setting an August 2026 PDUFA date for the first-in-class hepcidin mimetic in polycythemia vera, partnered with Takeda.
The quarter's headline event was Protagonist's April 28 election to opt out of U.S. profit-sharing on rusfertide. The move triggers a $200 million immediate payment, an additional $200 million opt-out fee, and a $75 million approval milestone, while shifting economics to 14–29% worldwide royalties (approximately 21% weighted-average at $1.5 billion in annual sales) and up to $775 million in sales milestones. The opt-out trades operational involvement for higher-margin royalty income and crystallizes near-term cash ahead of the August regulatory decision. Q1 financials showed $56.4 million in revenue (largely the ICOTYDE milestone), net income of $3.8 million, and a cash position of $620.3 million with runway through at least 2028. Wholly-owned pipeline programs PN-881 (oral IL-17 antagonist) and PN-477 (triple incretin agonist) are advancing toward mid-2026 and 2027 Phase 1 readouts, respectively.
Section-by-Section Diff
Event · Exhibit 99.1
PTGX reports Q1 2026 results: ICOTYDE FDA approval triggered $50M milestone; rusfertide NDA granted Priority Review; exercised opt-out for $200M fee.
Added in current filing · view on EDGAR →
On March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and granted Priority Review. The application is supported by data from the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term extension THRIVE study. The FDA set a PDUFA goal date in August 2026.
The FDA accepted the rusfertide NDA and granted Priority Review, setting a PDUFA target action date in August 2026 (third quarter). Rusfertide is a first-in-class hepcidin mimetic peptide for polycythemia vera, partnered with Takeda. Priority Review accelerates the review timeline to six months instead of the standard ten.
Added in current filing · view on EDGAR → · paraphrased
License and collaboration revenue of $56.4 million for the period ended March 31, 2026 consisted of (i) a $50.0 million milestone earned from JNJ in Q1 26 upon FDA approval of ICOTYDE, (ii) $3.3 million allocated to development services provided by us under the Takeda agreement during the period and (iii) $3.1 million cost reimbursement from Takeda for rusfertide clinical trial supplies. ... Research and development expense ... $46,739 ... General and administrative expense ... $13,277 ... Net income (loss) ... $3,783
Protagonist reported Q1 2026 revenue of $56.4 million (primarily the $50 million ICOTYDE milestone), R&D expense of $46.7 million, G&A expense of $13.3 million, and net income of $3.8 million ($0.06 per basic share).
Event · Item 2.02 — Results of Operations and Financial Condition
Protagonist Therapeutics reported Q1 2026 financial results and provided a corporate update via press release.
Added in current filing · verify on EDGAR →
On May 5, 2026, Protagonist Therapeutics, Inc. reported its financial results for the quarter ended March 31, 2026.
The company disclosed its first quarter 2026 financial results through a press release. The 8-K body does not contain specific financial figures; those details are in the attached press release exhibit. This is a routine quarterly earnings announcement.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 24, 2026 · How we verify