other material
confidence high
sentiment positive
materiality 0.85
Abeona Phase 3 VIITAL study of EB-101 meets co-primary endpoints; BLA submission planned Q2 2023
ABEONA THERAPEUTICS INC.
- 81.4% of treated wounds achieved ≥50% healing vs 16.3% controls (p<0.0001).
- Pain reduction co-primary endpoint met: mean reduction 3.07 treated vs 0.90 control (p=0.0002).
- No serious treatment-related adverse events; consistent with past safety profile.
- BLA submission to FDA for EB-101 in RDEB targeted for Q2 2023.
- EB-101 has Orphan Drug and Rare Pediatric Disease designations, may qualify for Priority Review Voucher.