Abeona Therapeutics: FDA accepts BLA resubmission for pz-cel; PDUFA date April 29, 2025

ABEONA THERAPEUTICS INC.

FDA accepted for review Abeona's resubmitted BLA for pz-cel (autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa).
PDUFA target action date assigned: April 29, 2025.
Resubmission supported by Phase 3 VIITAL and Phase 1/2a data with up to 8 years of follow-up.
If approved, pz-cel would be first autologous cell-based gene therapy for RDEB; Abeona may be eligible for a Priority Review Voucher.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.