---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-22-030288"
form_type: "8-K"
ticker: "ABEO"
cik: "0000318306"
company_name: "ABEONA THERAPEUTICS INC."
filed_at: "2022-11-03T23:59:59+00:00"
generated_at: "2026-06-22T10:03:05.168287+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Abeona Phase 3 VIITAL study of EB-101 meets co-primary endpoints; BLA submission planned Q2 2023

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-22-030288
- form_type: 8-K
- ticker: ABEO
- cik: 0000318306
- company_name: ABEONA THERAPEUTICS INC.
- filed_at: 2022-11-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/318306/000149315222030288/0001493152-22-030288-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/318306/000149315222030288/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-22-030288
- JSON: https://secwatch.observer/filing/0001493152-22-030288.json
- Plain text: https://secwatch.observer/filing/0001493152-22-030288.txt

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