Abeona Therapeutics’ Gene Therapy Gets FDA Nod For Treating Rare Genetic Skin Disease

ZEVASKYN is expected to be available beginning in the third quarter of 2025 through ZEVASKYN Qualified Treatment Centers, located across the U.S. with experience in cell and gene therapy.

Shares of Abeona Therapeutics Inc. (ABEO) were in the spotlight on Tuesday afternoon after it announced that the U.S. Food and Drug Administration (FDA) has approved its gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa.

Recessive dystrophic epidermolysis bullosa (RDEB) is a genetic skin disease with no known cure caused by a defect in the COL7A1 gene that leaves them unable to produce functioning type VII collagen.

Patients with the disease have fragile skin characterized by extensive blistering and severe wounds that often cover more than 30% of the body surface. These wounds are difficult to heal, can remain open for years, and many that do close tend to reopen.

Abeona stated that its ZEVASKYN sheet is the only FDA-approved product for treating RDEB wounds with a single application.

ZEVASKYN consists of a patient’s skin cells that have been genetically modified to produce functional Type VII collagen. These sheets are then surgically applied to the patient’s wounded areas.

Up to 12 credit card-sized sheets can be joined together to cover large areas in a single application, the company said.

ZEVASKYN is expected to be available beginning in the third quarter of 2025 through ZEVASKYN Qualified Treatment Centers (QTCs), which are treatment centers located across the U.S. with experience in cell and gene therapy.

However, H.C. Wainwright stated on Tuesday that it does not expect ZEVASKYN to have an immediate impact on Krystal Biotech’s Vyjuvek. Vyjuvek is a topical gel aimed at wound healing in patients with dystrophic epidermolysis bullosa.

Vyjuvek remains the "differentiated opportunity, particularly with regard to cost, surface area coverage for wound healing and quality of life/convenience," the analyst told investors in a research note, as per TheFly.

ABEO stock is down by about 16% this year but up by over 44% over the past 12 months.

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