1. Abeona treats its first commercial patient with FDA-approved ZEVASKYN. 2. ZEVASKYN is the first autologous gene therapy for recessive dystrophic epidermolysis bullosa. 3. Initial patient treatment conducted at Lucile Packard Children’s Hospital Stanford. 4. More patients are scheduled for treatment in the coming year. 5. ZEVASKYN shows potential for significant wound healing and pain reduction.
FAQ
Why Very Bullish?
Abeona's first successful treatment with ZEVASKYN creates positive market sentiment. Historical patterns show new therapies drive stock prices up, as seen with CAR-T therapies.
How important is it?
First commercial treatment positions Abeona as a leader in gene therapy, attracting investor interest. The rarity of RDEB highlights the unmet medical need, enhancing market potential.
Why Long Term?
ZEVASKYN's potential in treating RDEB could establish a profitable market presence over time. Sustained demand for innovative treatments may increase stock valuations.
Abeona Therapeutics® Announces First Patient Treatment with ZEVASKYN® Gene Therapy
CLEVELAND, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) has made a significant advancement in gene therapy by announcing the first commercial patient treatment with ZEVASKYN® (prademagene zamikeracel). This groundbreaking autologous gene therapy aims to treat wounds in both adult and pediatric patients suffering from recessive dystrophic epidermolysis bullosa (RDEB). The first administration took place at Lucile Packard Children’s Hospital Stanford in Palo Alto, CA.
CEO Statement on ZEVASKYN Milestone
“Treating our first patient is a proud moment for Abeona and a testament to the tireless resolve of our team,” stated Vish Seshadri, Chief Executive Officer of Abeona. “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.”
Expert Insight on RDEB Treatments
Dr. Joyce Teng, MD, PhD, a professor of dermatology at Stanford Medicine and chief of pediatric dermatology at Stanford Medicine Children’s Health, remarked, “We continually pursue new therapies to support patients enduring the lifelong pain and extensive wound care that RDEB demands, and work to provide care and hope to patients and families.”
Abeona Assist®: Patient Support Services
Abeona offers comprehensive patient support services through Abeona Assist®, helping eligible patients navigate their insurance benefits and identify financial assistance options. For more information on accessing ZEVASKYN, patients can visit www.abeonaassist.com, call 1-855-ABEONA-1 (1-855-223-6621), or email MyNavigator@AbeonaAssist.com.
Understanding Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Recessive dystrophic epidermolysis bullosa (RDEB) is a rare, life-altering blistering disorder characterized by severe skin wounds that result in considerable pain and can lead to systemic complications. Individuals with RDEB have defects in both copies of the COL7A1 gene, which is crucial for producing functional type VII collagen necessary for skin integrity.
About ZEVASKYN® Therapy
ZEVASKYN is recognized as the first and only autologous cell sheet-based gene therapy for treating RDEB wounds. By incorporating the functional type VII collagen-producing COL7A1 gene into patients' own skin cells ex vivo, ZEVASKYN effectively generates the collagen needed to maintain healthy skin. This innovative therapy has shown clinically meaningful outcomes in terms of wound healing and pain reduction following a single surgical application.
For more details, visit www.ZEVASKYN.com.
Safety Information
Patients receiving ZEVASKYN may experience serious allergic reactions, including symptoms like itching and difficulty breathing. There is also a potential risk that the treatment could contribute to cancer development, necessitating lifelong monitoring for patients. Common side effects include procedural pain and itching. More extensive side effects can be reported to Abeona at 1-844-888-2236 or to the FDA at 1-800-FDA-1088.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. With its ZEVASKYN therapy, Abeona is positioned as a leader in the treatment of RDEB. The company operates a state-of-the-art cGMP manufacturing facility in Cleveland, Ohio, dedicated to the production of ZEVASKYN. Their portfolio also includes numerous adeno-associated virus (AAV)-based gene therapies targeting significant unmet medical needs.
For further information, visit www.abeonatherapeutics.com.
Forward-Looking Statements
This press release includes forward-looking statements related to the future performance and potential of ZEVASKYN and Abeona Therapeutics. Various risks and uncertainties may cause actual results to differ from those anticipated. The company undertakes no obligation to update these statements as circumstances change, except as required by law.