---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-046978"
form_type: "8-K"
ticker: "KYNB"
cik: "0000921299"
company_name: "KYNTRA BIO, INC."
filed_at: "2025-03-31T23:59:59+00:00"
generated_at: "2026-05-24T02:47:06.130065+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FibroGen publishes Phase 1 FG-3246 mCRPC data in JCO; ORR 20%, DCR 80%, mid-2025 Phase 2 start

## Summary
- Phase 1 study of FG-3246 (anti-CD46 ADC) in mCRPC published in Journal of Clinical Oncology.
- Confirmed ORR 20%, DCR 80%, median rPFS 8.7 months in evaluable patients.
- PSA50 response rate 36% in 39 evaluable patients; half of docetaxel-sensitive patients responded.
- Safety profile consistent with MMAE ADCs; ocular AEs infrequent; MTD 2.7 mg/kg every 3 weeks.
- Phase 2 monotherapy dose optimization to start by mid-2025; combo enzalutamide topline in 2H 2025.

## SEC filing metadata
- accession: 0000950170-25-046978
- form_type: 8-K
- ticker: KYNB
- cik: 0000921299
- company_name: KYNTRA BIO, INC.
- filed_at: 2025-03-31T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/921299/000095017025046978/0000950170-25-046978-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/921299/000095017025046978/fgen-20250328.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-046978
- JSON: https://secwatch.observer/filing/0000950170-25-046978.json
- Plain text: https://secwatch.observer/filing/0000950170-25-046978.txt

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