Abeona Therapeutics Soars 12.15% on FDA Gene Therapy Approval

Abeona Therapeutics' stock surged 12.15% in pre-market trading on April 29, 2025, following the U.S. Food and Drug Administration's approval of its gene therapy for a rare skin disorder.

The FDA's approval of ZEVASKYN, the first and only FDA-approved autologous cell-based gene therapy for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB), marks a significant milestone for Abeona Therapeutics. This approval is based on the pivotal Phase 3 VIITAL study, which demonstrated that 81% of treated wounds showed 50% or more healing after six months, compared to only 16% with standard care. The therapy uses patients' own skin cells, modified to produce Type VII collagen, addressing the underlying genetic cause of RDEB.

The therapy is expected to be available through Qualified Treatment Centers beginning in the third quarter of 2025. Abeona Therapeutics also received a Rare Pediatric Disease Priority Review Voucher, which the company plans to monetize, providing additional financial value. The company's comprehensive patient support program, Abeona Assist, will offer personalized support, including insurance benefits guidance and financial assistance options, to ensure access to the therapy.