Abeona Therapeutics® Announces New Qualified Treatment Center for ZEVASKYN® in Texas
Rhea-AI Summary
Abeona Therapeutics (Nasdaq: ABEO) announced on December 11, 2025 that The University of Texas Medical Branch (UTMB) in Galveston is now an activated Qualified Treatment Center (QTC) for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets.
ZEVASKYN is an FDA-approved autologous gene therapy for adult and pediatric wounds caused by recessive dystrophic epidermolysis bullosa (RDEB). UTMB is described as a major academic center with expertise in complex skin disease and wound care. The announcement emphasizes expanded patient access across Texas and the Gulf Coast and points to Abeona Assist for patient support, insurance help, and logistical assistance.
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Market Reality Check
Peers on Argus
Biotech peers showed mostly positive moves (e.g., RCKT up 7.4%, AUTL up 2%, TECX up 2.94%, DSGN up 2.39%, IMRX down 0.81%), but no coordinated sector momentum was flagged for this news.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 08 | Commercial milestone | Positive | +5.3% | First commercial ZEVASKYN treatment for an RDEB patient in California. |
| Dec 01 | Equity inducement grants | Neutral | -5.7% | Restricted stock awards to two new non-executive employees under Nasdaq rules. |
| Nov 12 | Q3 2025 earnings | Positive | +18.5% | Q3 results with strong cash position and early ZEVASKYN demand indicators. |
| Nov 07 | Earnings call scheduling | Neutral | +0.2% | Announcement of Q3 results call and Stifel conference participation dates. |
| Nov 03 | Equity inducement grants | Neutral | -0.6% | Inducement restricted stock awards to eleven new hires under Nasdaq Rule 5635(c)(4). |
ABEO has shown strong positive reactions to ZEVASKYN commercialization and earnings updates, while routine corporate or equity grant news has had modest, mixed impact.
Over the last two months, Abeona progressed from anticipating ZEVASKYN commercialization to reporting Q3 2025 results and then treating the first commercial patient on Dec 8, 2025, which saw a 5.34% price gain. The Q3 report on Nov 12, 2025 brought an 18.47% move, reflecting investor focus on cash, operating spend, and early demand signals. By comparison, multiple employee inducement grant announcements in November and December drew modest negative or flat reactions, highlighting that investors have been more responsive to commercialization milestones than routine corporate items. Today’s new treatment center update fits into this commercialization build-out theme.
Market Pulse Summary
This announcement adds another Qualified Treatment Center in Texas for ZEVASKYN, extending access for adults and children with recessive dystrophic epidermolysis bullosa. It follows recent milestones including Q3 2025 results and the first commercial treatment, underscoring Abeona’s focus on building out its commercial network. Investors may watch for further center activations, measured uptake trends, and ongoing regulatory disclosures, alongside any additional insider activity, to gauge how effectively this infrastructure build-out supports long-term utilization.
Key Terms
autologous medical
gene therapy medical
recessive dystrophic epidermolysis bullosa medical
FDA-approved regulatory
AI-generated analysis. Not financial advice.
CLEVELAND, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced activation of The University of Texas Medical Branch (UTMB) in Galveston, Texas, as the newest Qualified Treatment Center (QTC) for the administration of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets. ZEVASKYN, a first-of-its-kind, FDA-approved autologous, gene therapy is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
UTMB, home to the first department of dermatology in Texas, is a major academic medical center renowned for its comprehensive complex skin disease and wound care.
“Activation of UTMB as a QTC significantly expands patient access to ZEVASKYN across Texas and the Gulf Coast region,” said Dr. Madhav Vasanthavada, Chief Commercial Officer of Abeona. “We are deeply impressed by UTMB's unwavering commitment to bringing transformative care to their community. Their focus on innovation makes them an ideal partner to deliver ZEVASKYN to patients in need.”
“Patients with RDEB endure a life of chronic, painful blistering and open wounds. The persistent need for daily wound care and the lack of disease-modifying therapies have historically placed an immense burden on patients and their families,” said Dr. Michael G. Wilkerson, MD, Professor and Chair of the Department of Dermatology at UTMB. “We are proud to be a designated treatment center for ZEVASKYN and to be at the forefront of delivering this novel, FDA-approved gene therapy that offers new hope for healing debilitating wounds associated with this disease.”
For more information on how to access ZEVASKYN and learn about patient support services offered through Abeona Assist®, Abeona’s comprehensive patient support program, visit www.abeonaassist.com, call 1-855-ABEONA-1 (1-855-223-6621) or email MyNavigator@AbeonaAssist.com. Abeona Assist offers personalized support, including helping eligible patients understand their insurance benefits and financial assistance options, and providing travel and logistical assistance.
About recessive dystrophic epidermolysis bullosa
Recessive dystrophic epidermolysis bullosa (RDEB), a rare blistering disorder without a cure, is characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in both copies of the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which is necessary to anchor the dermal and epidermal layers of the skin.
About ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheets
ZEVASKYN is the first and only autologous cell sheet-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a severe skin disease caused by a defect in both copies of the COL7A1 gene resulting in the inability to produce functional type VII collagen. Without functional type VII collagen and anchoring fibrils, the skin is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Patients often have large open wounds that can lead to serious life-threatening complications. ZEVASKYN incorporates the functional type VII collagen-producing COL7A1 gene into a patient’s own skin cells, ex vivo, using a replication-incompetent retroviral vector to produce functional type VII collagen in treated wounds. ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application. For more information, visit www.ZEVASKYN.com.
Indication
ZEVASKYN® (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Important Safety Information
- Serious allergic reactions to ZEVASKYN can occur. Patients should get medical help right away if they experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen.
- There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer.
- ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated.
- The most common side effects are pain from the procedure and itching.
This is not a complete list of side effects. Patients should call their care team for medical advice about side effects. Side effects may be reported to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See full Prescribing Information.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated for a variety of devastating diseases. For more information, visit www.abeonatherapeutics.com.
ZEVASKYN®, Abeona Assist®, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.
Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, our ability to successfully commercialize and market ZEVASKYN, including manufacturing sufficient batches of ZEVASKYN to meet demand; the therapeutic potential of ZEVASKYN; whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company’s expectations; continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with and inspections by the FDA or other regulatory agencies, including those relating to preclinical programs and to the cGMP manufacturing of ZEVASKYN; the ability to achieve or obtain necessary regulatory approvals for our pre-clinical programs; the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to U.S. trade policy, such as current or future tariffs; risks associated with data analysis and reporting; and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise these forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Contacts:
Investor and Media
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
Investor
Lee M. Stern
Meru Advisors
lstern@meruadvisors.com
FAQ
What did Abeona announce about ZEVASKYN access on December 11, 2025 for ABEO?
What is ZEVASKYN (prademagene zamikeracel) and who is it approved for?
How can patients access ZEVASKYN and support services from Abeona (ABEO)?
Why is UTMB Galveston significant as a Qualified Treatment Center for ABEO?
Does the announcement state any changes to ZEVASKYN's FDA approval status for ABEO?
Who at UTMB commented on becoming a treatment center for ZEVASKYN on behalf of ABEO news?
