Abeona Therapeutics secured FDA approval for ZEVASKYN in April 2025, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa wounds. The company has initiated commercialization with an expanding network of qualified treatment centers and secured critical reimbursement designations including a permanent CMS J-code. Despite this progress, Abeona reported a significant operating loss of $89.4 million in FY2025 amid elevated investments in manufacturing scale-up and commercialization infrastructure. Its pipeline includes early-stage AAV-based ophthalmic gene therapies leveraging proprietary capsid technology, reflecting a long-term growth focus amid regulatory and operational challenges.