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

ABEONA THERAPEUTICS INC.

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.

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