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

ABEO
  • Abeona Therapeutics announced progress on the commercial launch of FDA-approved ZEVASKYN (prademagene zamikeracel), an autologous gene therapy for wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).
  • Commercial launch activities began in Q4 2025 following 2025 optimization of a release assay, with the first patient treated in December prior to a facility shutdown.
  • Manufacturing resumed in late January 2026, resulting in multiple collected biopsies, one completed treatment, ongoing manufacturing runs, and additional biopsy schedules for the current quarter.
  • Initial Qualified Treatment Centers are gaining familiarity with administrative processes, and the company observes growing interest among patients and physicians.
  • ZEVASKYN has secured coverage policies from all major commercial payers, including United Healthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans, which cover 80 percent of commercial insurance lives.
  • The therapy has also obtained coverage across all Medicaid programs.
  • The Centers for Medicare and Medicaid Services established a permanent HCPCS J-code (J3389) for ZEVASKYN effective January 1, 2026, to streamline billing and reimbursement.
  • RDEB is a rare, incurable blistering disorder caused by a defect in both copies of the COL7A1 gene, preventing the production of functional type VII collagen.
  • ZEVASKYN is the first autologous cell sheet-based gene therapy for RDEB, utilizing a replication-incompetent retroviral vector to introduce the functional COL7A1 gene into patient skin cells ex vivo.
  • The therapy has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application.
  • Safety information highlights risks of serious allergic reactions, potential cancer development requiring lifelong monitoring, infection risks from human or animal materials, and common side effects including procedure-related pain and itching.
  • Abeona Therapeutics operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, for commercial ZEVASKYN production.