---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-019516"
form_type: "8-K"
ticker: "PTGX"
cik: "0001377121"
company_name: "Protagonist Therapeutics, Inc"
filed_at: "2025-03-03T23:59:59+00:00"
generated_at: "2026-05-25T17:10:13.259653+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Protagonist and Takeda announce positive Phase 3 topline data for rusfertide in polycythemia vera; primary endpoint met

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-019516
- form_type: 8-K
- ticker: PTGX
- cik: 0001377121
- company_name: Protagonist Therapeutics, Inc
- filed_at: 2025-03-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1377121/000110465925019516/0001104659-25-019516-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1377121/000110465925019516/tm258056d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-019516
- JSON: https://secwatch.observer/filing/0001104659-25-019516.json
- Plain text: https://secwatch.observer/filing/0001104659-25-019516.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.