secwatch.observer — SEC 8-K summary
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Issuer:     Protagonist Therapeutics, Inc (PTGX)
CIK:        0001377121
Form:       8-K
Filed at:   2025-03-03T23:59:59+00:00
Accession:  0001104659-25-019516
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Protagonist and Takeda announce positive Phase 3 topline data for rusfertide in polycythemia vera; primary endpoint met
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- 77% of rusfertide patients achieved clinical response vs 33% placebo (p<0.0001) during weeks 20-32.
- Mean phlebotomies per patient: 0.5 rusfertide vs 1.8 placebo (p<0.0001) over 32 weeks (EU primary endpoint).
- All four key secondary endpoints met, including hematocrit control and patient-reported outcomes.
- Safety profile consistent with prior studies; no new safety signals; serious AEs not drug-related.
- NDA filing for rusfertide expected in second half of 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1377121/000110465925019516/0001104659-25-019516-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1377121/000110465925019516/tm258056d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-019516

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