secwatch.observer — SEC 8-K summary
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Issuer:     Protagonist Therapeutics, Inc (PTGX)
CIK:        0001377121
Form:       8-K
Filed at:   2024-01-08T23:59:59+00:00
Accession:  0001104659-24-002073
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Protagonist updates pipeline: rusfertide Ph3 enrollment Q1 2024; JNJ-2113 Ph3 psoriasis data Nov 2024
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- Rusfertide Phase 3 VERIFY study enrollment completion expected Q1 2024; primary endpoint similar to Phase 2.
- Phase 2 REVIVE showed 69.2% responder rate vs 18.5% placebo (p=0.0003); durable Hct control to 2.5 years.
- Rusfertide improved fatigue (p=0.0074) and concentration (p=0.0018) scores; ferritin normalized over 2.5 years.
- JNJ-2113 Phase 3 ICONIC-LEAD psoriasis primary completion ~Nov 2024; Phase 2b ANTHEM UC completion ~Nov 2024.
- Anticipated rusfertide NDA filing Q4 2026; JNJ-2113 NDA filing expected 2025/2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1377121/000110465924002073/0001104659-24-002073-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1377121/000110465924002073/tm242310d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-002073

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