Abeona Therapeutics Inc. announced on April 29, 2025, that the U.S. Food and Drug Administration (FDA) has approved ZEVASKYN™ (prademagene zamikeracel) gene-modified cellular sheets. ZEVASKYN is the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a severe and debilitating genetic skin disease. This approval marks a pivotal moment for the RDEB community, as there is no cure for the condition and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application.
The FDA approval is based on data from the pivotal Phase 3 VIITAL™ study, which met its two co-primary efficacy endpoints. The study demonstrated statistically significant healing of 50 percent or more from baseline in large chronic RDEB wounds, and pain reduction from baseline, both evaluated at six months after treatment. Across 43 treated wounds, 81 percent showed 50 percent or more healing, compared to 16 percent in control wounds. ZEVASKYN was well-tolerated in clinical studies, with no treatment-related serious adverse events observed.
In connection with the FDA approval, Abeona received a Rare Pediatric Disease Priority Review Voucher (PRV), which the company plans to monetize. ZEVASKYN is expected to be available through Qualified Treatment Centers starting in the third quarter of 2025, supported by the Abeona Assist™ patient services program. This approval transforms Abeona into a commercial-stage company and addresses a significant unmet medical need.
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