ABEONA THERAPEUTICS INC.
Business Abeona Therapeutics Inc., a Delaware corporation (together with our subsidiaries, we, our, Abeona or the Company ), is a commercial-stage biopharmaceutical company developing cell and gene th…
Business Abeona Therapeutics Inc., a Delaware corporation (together with our subsidiaries, we, our, Abeona or the Company ), is a commercial-stage biopharmaceutical company 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 the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa ( RDEB ), a serious and debilitating genetic skin disease. There is no cure for RDEB, and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single surgical application. ZEVASKYN was granted Orphan Drug and Rare Pediatric Disease designations by the FDA ZEVASKYN is manufactured at our current Good Manufacturing Practices ( cGMP ) manufacturing facility in Cleveland, Ohio. Treatments are available through ZEVASKYN qualified treatment centers, a network of centers that are selected based on their expertise in cell and gene therapy and trained to administer ZEVASKYN . As of March 2026, we have activated 4 qualified treatment centers and are in discussions with additional centers as we continue to expand the ZEVASKYN qualified treatment network. The Company’s development portfolio also features adeno-associated virus ( AAV )-based gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM capsids.
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