Abeona Therapeutics Inc. (NASDAQ: ABEO) administered its first commercial dose of ZEVASKYN (prademagene zamikeracel) to a patient at Lucile Packard Children’s Hospital Stanford in Palo Alto, California, on December 8 2025. The treatment represents the first real‑world use of the company’s FDA‑approved autologous cell‑based gene therapy for wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).
ZEVASKYN received FDA approval on April 29 2025 after the Phase 3 VIITAL study demonstrated significant wound healing and pain reduction. The December 8 administration confirms that Abeona’s manufacturing, regulatory, and clinical support infrastructure are fully operational and that the therapy can be delivered in a commercial setting. This milestone is a critical step toward generating revenue and validating the company’s business model in a rare‑disease market with no curative options.
Abeona’s Q3 2025 financial results show a net loss of $5.2 million, a dramatic improvement from the $30.3 million loss reported in Q3 2024. The company reported $207.5 million in cash and equivalents as of September 30 2025, providing a runway of more than two years to support the commercial launch and early‑stage patient treatment program. The strong cash position underpins the company’s ability to scale production and expand its Qualified Treatment Center (QTC) network.
The company had originally planned a commercial launch in Q3 2025, but the FDA’s requirement for a rapid sterility release assay delayed the start to Q4 2025. Despite the delay, the first patient was treated on December 8, and additional patients are already scheduled for the new year as the QTCs ramp up capacity. The early commercial use demonstrates that the assay optimization has been resolved and that the supply chain can meet patient demand.
ZEVASKYN competes with Krystal Biotech’s Vyjuvek, a topical gene therapy for RDEB. While Vyjuvek targets superficial wounds, ZEVASKYN is designed for large, deep, and refractory wounds, positioning the two products as complementary rather than direct substitutes. The dual‑product landscape expands treatment options for the RDEB community and may broaden Abeona’s market share over time.
CEO Vish Seshadri said, “Treating our first patient is a proud moment for Abeona and a testament to the tireless resolve of our team. We are humbled to bring ZEVASKYN to the RDEB community and grateful to our growing network of Qualified Treatment Centers. Momentum is building, with additional patients already scheduled for treatment in the new year.” The statement underscores the company’s confidence in its commercial strategy and the expected acceleration of patient enrollment as the QTC network expands.
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