secwatch.observer — SEC 8-K summary
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Issuer:     KYNTRA BIO, INC. (KYNB)
CIK:        0000921299
Form:       8-K
Filed at:   2025-03-31T23:59:59+00:00
Accession:  0000950170-25-046978
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/921299/000095017025046978/0000950170-25-046978-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/921299/000095017025046978/fgen-20250328.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-046978

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