---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-042711"
form_type: "8-K"
ticker: "ABEO"
cik: "0000318306"
company_name: "ABEONA THERAPEUTICS INC."
filed_at: "2023-11-27T23:59:59+00:00"
generated_at: "2026-06-07T21:42:36.311015+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts and grants Priority Review for Abeona's pz-cel BLA; PDUFA date May 25, 2024

## Summary
- FDA accepted BLA for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB) with Priority Review.
- PDUFA target action date set for May 25, 2024.
- FDA does not currently plan to hold an Advisory Committee meeting for pz-cel BLA.
- BLA supported by data from Phase 3 VIITAL study and Phase 1/2a study showing sustained wound healing and pain reduction.
- Priority Review grants eligibility for a Priority Review Voucher.

## SEC filing metadata
- accession: 0001493152-23-042711
- form_type: 8-K
- ticker: ABEO
- cik: 0000318306
- company_name: ABEONA THERAPEUTICS INC.
- filed_at: 2023-11-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/318306/000149315223042711/0001493152-23-042711-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/318306/000149315223042711/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-042711
- JSON: https://secwatch.observer/filing/0001493152-23-042711.json
- Plain text: https://secwatch.observer/filing/0001493152-23-042711.txt

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