---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-015531"
form_type: "8-K"
ticker: "ABEO"
cik: "0000318306"
company_name: "ABEONA THERAPEUTICS INC."
filed_at: "2024-04-22T23:59:59+00:00"
generated_at: "2026-06-03T14:39:58.613122+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Abeona receives FDA Complete Response Letter for pz-cel BLA due to CMC deficiencies

## Summary
- FDA CRL for pz-cel BLA cites additional CMC information needed; no clinical efficacy/safety deficiencies.
- No new clinical trials or clinical data requested by FDA for approval.
- Company expects to complete BLA resubmission with requested CMC data in Q3 2024.
- PDUFA date of May 25, 2024 will be missed due to proposed timing of data submission.

## SEC filing metadata
- accession: 0001493152-24-015531
- form_type: 8-K
- ticker: ABEO
- cik: 0000318306
- company_name: ABEONA THERAPEUTICS INC.
- filed_at: 2024-04-22T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/318306/000149315224015531/0001493152-24-015531-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/318306/000149315224015531/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-015531
- JSON: https://secwatch.observer/filing/0001493152-24-015531.json
- Plain text: https://secwatch.observer/filing/0001493152-24-015531.txt

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