Abeona Expands ZEVASKYN Access with UTMB Activation as Qualified Treatment Center

ABEO
December 11, 2025

Abeona Therapeutics announced that the University of Texas Medical Branch in Galveston has been activated as a new Qualified Treatment Center for its FDA‑approved autologous gene therapy, ZEVASKYN (prademagene zamikeracel). The activation expands patient access to the therapy across Texas and the Gulf Coast, adding a major academic medical center with a strong dermatology and wound‑care program to Abeona’s growing QTC network.

ZEVASKYN is the first autologous cell‑based gene therapy approved in the United States for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). The therapy received FDA approval on April 29 2025, and the first commercial treatment was administered on December 8 2025. A permanent CMS J‑code for ZEVASKYN became effective on January 1 2026, securing payer coverage and streamlining reimbursement for the product.

Abeona’s Q3 2025 financial results underscored the commercial momentum behind ZEVASKYN. The company reported earnings per share of –$0.10, beating analyst expectations of –$0.29 by $0.19, a 65% improvement that reflects disciplined cost management and a higher mix of commercial treatments. Net income of $5.16 million also surpassed the consensus estimate of –$16.90 million, while operating income of –$24.02 million missed expectations of –$18.20 million due to one‑time regulatory and compliance costs. As of September 30 2025, Abeona held $207.5 million in cash and equivalents, providing a runway of more than two years to support the expanding commercial launch.

Management highlighted the strategic significance of the UTMB activation. Chief Commercial Officer Dr. Madhav Vasanthavada said the partnership “significantly expands patient access to ZEVASKYN across Texas and the Gulf Coast region” and praised UTMB’s focus on innovation. Dr. Michael G. Wilkerson, Chair of UTMB’s Dermatology Department, expressed pride in being a designated treatment center and noted that ZEVASKYN offers “new hope for healing debilitating wounds.” CEO Vish Seshadri emphasized the company’s confidence in meeting growing patient demand and the importance of building a robust QTC network.

The announcement was well received by investors and analysts, who viewed the expansion as a key driver of positive sentiment. Analysts noted that the addition of a high‑profile academic center strengthens Abeona’s commercial infrastructure and positions the company to capture a larger share of the RDEB market as demand for ZEVASKYN continues to rise.

Strategically, the UTMB activation is part of Abeona’s broader plan to scale its QTC network and accelerate treatment volumes. By adding a center with strong dermatology and wound‑care capabilities, the company can reduce geographic barriers for patients and streamline logistics for cell‑therapy manufacturing and delivery. While the company faces headwinds such as the need for ongoing regulatory oversight and the inherent risks of gene‑therapy manufacturing, the expansion signals confidence in the therapy’s commercial viability and positions Abeona to capitalize on the growing RDEB patient population.

The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.