Abeona Therapeutics Inc.

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for life-threatening diseases. On April 28, 2025, the U.S. Food and Drug Administration (FDA) approved ZEVASKYN ® (prademagene zamikeracel) gene-modified cellular sheets, also known as ZEVASKYN ® , as the first and only autologous cell-based gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease. ZEVASKYN ® is the only FDA-approved product to treat RDEB wounds with a single surgical application and was granted Orphan Drug and Rare Pediatric Disease designations by the FDA. ZEVASKYN ® is manufactured at the company's current Good Manufacturing Practices (cGMP) facility in Cleveland, Ohio. Treatments are provided through ZEVASKYN ® qualified treatment centers, a network selected for their expertise in cell and gene therapy and trained to administer ZEVASKYN ® . As of March 2026, Abeona has activated 4 qualified treatment centers and is expanding this network. The company's development portfolio also includes adeno-associated virus (AAV)-based gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM™ capsids. Abeona partners with academic researchers, patient advocacy organizations, caregivers, and other biotechnology companies to develop therapies for rare genetic diseases lacking effective treatment options. The company's strategy involves commercializing ZEVASKYN ® and advancing and commercializing its cell and gene therapy programs.