secwatch.observer — SEC 8-K summary
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Issuer:     Protagonist Therapeutics, Inc (PTGX)
CIK:        0001377121
Form:       8-K/A
Filed at:   2025-03-11T23:59:59+00:00
Accession:  0001104659-25-022615
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Icotrokinra shows positive Phase 2b UC (corrected p-value) and Phase 3 PsO top-line data
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- Phase 2b ANTHEM-UC: highest dose achieved 63.5% clinical response and 30.2% clinical remission at Wk12 vs 27.0% and 11.1% placebo; p-values corrected to <0.001 and <0.01.
- Phase 3 ICONIC-LEAD: 65% IGA 0/1 and 50% PASI 90 at Wk16; at Wk24: 74% IGA 0/1, 65% PASI 90; 46% completely clear skin.
- Phase 3 ICONIC-ADVANCE 1&2: met co-primary endpoints vs placebo; superior to deucravacitinib on all key secondary endpoints at Wk16 and Wk24.
- Initiation of ICONIC-ASCEND: first head-to-head study of oral icotrokinra vs injectable biologic (ustekinumab) in moderate-to-severe PsO.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1377121/000110465925022615/0001104659-25-022615-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1377121/000110465925022615/tm258886d1_8ka.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-022615

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer