---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-044514"
form_type: "8-K"
ticker: "ABEO"
cik: "0000318306"
company_name: "ABEONA THERAPEUTICS INC."
filed_at: "2024-11-12T23:59:59+00:00"
generated_at: "2026-05-30T02:24:39.879586+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Abeona Therapeutics: FDA accepts BLA resubmission for pz-cel; PDUFA date April 29, 2025

## Summary
- FDA accepted for review Abeona's resubmitted BLA for pz-cel (autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa).
- PDUFA target action date assigned: April 29, 2025.
- Resubmission supported by Phase 3 VIITAL and Phase 1/2a data with up to 8 years of follow-up.
- If approved, pz-cel would be first autologous cell-based gene therapy for RDEB; Abeona may be eligible for a Priority Review Voucher.

## SEC filing metadata
- accession: 0001493152-24-044514
- form_type: 8-K
- ticker: ABEO
- cik: 0000318306
- company_name: ABEONA THERAPEUTICS INC.
- filed_at: 2024-11-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/318306/000149315224044514/0001493152-24-044514-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/318306/000149315224044514/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-044514
- JSON: https://secwatch.observer/filing/0001493152-24-044514.json
- Plain text: https://secwatch.observer/filing/0001493152-24-044514.txt

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