FDA approves Abeona's ZEVASKYN, first cell-based gene therapy for RDEB

ABEONA THERAPEUTICS INC.

81% of ZEVASKYN-treated wounds achieved ≥50% healing at 6 months vs 16% control (P<0.0001) in Phase 3 VIITAL study.
Rare Pediatric Disease Priority Review Voucher granted; company plans to monetize the PRV.
ZEVASKYN available through Qualified Treatment Centers starting 3Q 2025; Abeona Assist support program launched.
CEO cites pivotal moment for RDEB community; single surgical application aims for long-term wound healing and pain reduction.

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