Abeona Therapeutics® Provides Business Update Highlighting Building Momentum in ZEVASKYN® Commercial Launch

Core Insights - Abeona Therapeutics Inc. has launched ZEVASKYN, an FDA-approved autologous gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][10] Company Update - The commercial launch of ZEVASKYN began in Q4 2025, with the first patient treatment completed in December 2025 [2] - Manufacturing resumed in late January 2026, with multiple biopsies collected and ongoing treatment processes [2] - The company is establishing a regular schedule for biopsy collections, indicating increased patient engagement and interest in ZEVASKYN [3] Market Access and Payer Engagement - ZEVASKYN has received coverage from all major commercial payers, including United Healthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans, covering 80% of lives under commercial insurance [4] - The therapy has also secured coverage across all Medicaid programs, enhancing its market acceptance [4] - A permanent HCPCS J-code (J3389) for ZEVASKYN was established by CMS, effective January 1, 2026, facilitating medical billing and reimbursement processes [4] Product Information - ZEVASKYN is the first autologous cell sheet-based gene therapy for RDEB, addressing a severe skin condition caused by defects in the COL7A1 gene [6][7] - The therapy incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, which is crucial for skin integrity [6] - Clinical results have shown meaningful wound healing and pain reduction with a single application of ZEVASKYN [6]