# FDA Approves Abeona's ZEVASKYN, First Autologous Cell-Based Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa

> fda · REPORTED · 2025-04-01

The FDA approved ZEVASKYN (prademagene zamikeracel) in April 2025, making it the first and only autologous cell-based gene therapy for wound treatment in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. Abeona reported strong early launch momentum with first patient treatment on track for Q3 2025 and positive insurance coverage established with multiple national payers.

About Abeona Therapeutics: Abeona Therapeutics is a clinical-stage gene and cell therapy company focused on rare genetic diseases, with its lead program targeting severe skin disorders including recessive dystrophic epidermolysis bullosa.

- Company: Abeona Therapeutics
- Sector: biotech
- Primary source: https://www.sec.gov/Archives/edgar/data/1590750/000119312525265711/d33707dex991.htm

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.