---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-042775"
form_type: "8-K"
ticker: "ABEO"
cik: "0000318306"
company_name: "ABEONA THERAPEUTICS INC."
filed_at: "2024-10-29T23:59:59+00:00"
generated_at: "2026-05-30T09:27:07.921302+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Abeona Therapeutics resubmits BLA for pz-cel gene therapy for RDEB to FDA

## Summary
- Resubmitted Biologics License Application (BLA) for pz-cel to FDA for recessive dystrophic epidermolysis bullosa (RDEB).
- Resubmission addresses all Chemistry Manufacturing and Controls (CMC) items from April 2024 Complete Response Letter.
- No new clinical trials or data requested; prior CRL had no deficiencies in safety or efficacy.
- FDA expected to set new PDUFA target action date; review period is 2 or 6 months based on classification.
- Pz-cel holds Regenerative Medicine Advanced Therapy, Breakthrough, Orphan, and Rare Pediatric Disease designations.

## SEC filing metadata
- accession: 0001493152-24-042775
- form_type: 8-K
- ticker: ABEO
- cik: 0000318306
- company_name: ABEONA THERAPEUTICS INC.
- filed_at: 2024-10-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/318306/000149315224042775/0001493152-24-042775-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/318306/000149315224042775/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-042775
- JSON: https://secwatch.observer/filing/0001493152-24-042775.json
- Plain text: https://secwatch.observer/filing/0001493152-24-042775.txt

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