other material
confidence high
sentiment negative
materiality 0.90
FibroGen Phase 3 ZEPHYRUS-1 trial of pamrevlumab for IPF fails primary endpoint
KYNTRA BIO, INC.
- Phase 3 ZEPHYRUS-1 did not meet primary endpoint: change in FVC at week 48 (p=0.29); placebo-corrected difference 70 ml.
- Secondary endpoint (disease progression or death) also not met (HR=0.78, 95% CI 0.52-1.15).
- ZEPHYRUS-2 Phase 3 IPF trial will be discontinued based on these results.
- Company plans cost reductions to extend cash runway into 2026; roxadustat commercialization continues.
- Upcoming milestones: DMD data 3Q 2023, pancreatic cancer data 1H 2024, new IND filings.