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

ABEONA THERAPEUTICS INC.

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.

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