regulatory
confidence high
sentiment negative
materiality 0.90
Soligenix Phase 3 FLASH2 trial of HyBryte for CTCL halted for futility
SOLIGENIX, INC.
- Data Monitoring Committee interim efficacy analysis recommended halt; HyBryte failed to show benefit at 18 weeks.
- Company reports ~$5.9M cash; evaluating strategic options including M&A or advancing dusquetide for Behçet's Disease.
- HyBryte previously showed statistically significant lesion reduction in Phase 3 FLASH study at 6 weeks, but not replicated in FLASH2.
- Soligenix plans further data analysis to identify patient subsets; will discuss with FDA and EMA if warranted.