Company description

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.

Read the full filing description · filed 17 Mar 2026

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Healthcare

Industry

Pharmaceutical Preparations