ZEVASKYN™ Gene Therapy Now Available at New Qualified Treatment Center in San Francisco Bay Area
Abeona Therapeutics (Nasdaq: ABEO) has activated a new Qualified Treatment Center (QTC) for ZEVASKYN, its FDA-approved gene therapy treatment, at Lucile Packard Children's Hospital Stanford. ZEVASKYN, approved in April 2025, is the first and only FDA-approved therapy to treat recessive dystrophic epidermolysis bullosa (RDEB) wounds with a single application.
The activation follows a decade-long research collaboration between Abeona and Stanford Medicine. The treatment is now available at both Stanford and Lurie Children's Hospital of Chicago. To support patient access, Abeona offers Abeona Assist™, a comprehensive support program providing insurance benefits assistance, financial support options, and travel logistics help.
Abeona Therapeutics (Nasdaq: ABEO) ha attivato un nuovo Centro di Trattamento Qualificato (QTC) per ZEVASKYN, la sua terapia genica approvata dalla FDA, presso il Lucile Packard Children's Hospital di Stanford. ZEVASKYN, approvato nell'aprile 2025, è la prima e unica terapia approvata dalla FDA per trattare le ferite da epidermolisi bollosa distrofica recessiva (RDEB) con una singola applicazione.
L'attivazione segue una collaborazione di ricerca durata un decennio tra Abeona e Stanford Medicine. Il trattamento è ora disponibile sia a Stanford che al Lurie Children's Hospital di Chicago. Per supportare l'accesso dei pazienti, Abeona offre Abeona Assist™, un programma di supporto completo che fornisce assistenza per i benefici assicurativi, opzioni di supporto finanziario e aiuto nella logistica dei viaggi.
Abeona Therapeutics (Nasdaq: ABEO) ha activado un nuevo Centro de Tratamiento Calificado (QTC) para ZEVASKYN, su terapia génica aprobada por la FDA, en el Hospital Infantil Lucile Packard de Stanford. ZEVASKYN, aprobado en abril de 2025, es la primera y única terapia aprobada por la FDA para tratar las heridas de epidermólisis bullosa distrófica recesiva (RDEB) con una sola aplicación.
La activación sigue una colaboración de investigación de una década entre Abeona y Stanford Medicine. El tratamiento ya está disponible tanto en Stanford como en el Hospital Infantil Lurie de Chicago. Para apoyar el acceso de los pacientes, Abeona ofrece Abeona Assist™, un programa integral de apoyo que brinda asistencia con beneficios de seguros, opciones de apoyo financiero y ayuda con la logística de viajes.
Abeona Therapeutics (나스닥: ABEO)가 루실 팩커드 아동병원 스탠포드에서 FDA 승인 유전자 치료제 ZEVASKYN의 새로운 자격 치료 센터(QTC)를 개설했습니다. 2025년 4월 승인된 ZEVASKYN은 단일 적용으로 열성 유전성 표피박리증(RDEB) 상처를 치료하는 FDA 승인 최초이자 유일한 치료제입니다.
이번 개설은 Abeona와 스탠포드 의과대학 간 10년에 걸친 연구 협력의 결과입니다. 치료는 현재 스탠포드와 시카고 루리 아동병원에서 이용 가능합니다. 환자 접근성을 지원하기 위해 Abeona는 보험 혜택 지원, 재정 지원 옵션, 여행 지원을 제공하는 종합 지원 프로그램 Abeona Assist™를 운영하고 있습니다.
Abeona Therapeutics (Nasdaq : ABEO) a activé un nouveau Centre de Traitement Qualifié (QTC) pour ZEVASKYN, son traitement de thérapie génique approuvé par la FDA, au Lucile Packard Children's Hospital de Stanford. ZEVASKYN, approuvé en avril 2025, est la première et unique thérapie approuvée par la FDA pour traiter les plaies de l’épidermolyse bulleuse dystrophique récessive (RDEB) avec une seule application.
Cette activation fait suite à une collaboration de recherche de dix ans entre Abeona et Stanford Medicine. Le traitement est désormais disponible à Stanford ainsi qu’au Lurie Children's Hospital de Chicago. Pour faciliter l’accès des patients, Abeona propose Abeona Assist™, un programme complet d’accompagnement offrant une assistance pour les prestations d’assurance, des options de soutien financier et une aide à la logistique des déplacements.
Abeona Therapeutics (Nasdaq: ABEO) hat ein neues Qualifiziertes Behandlungszentrum (QTC) für ZEVASKYN, seine von der FDA zugelassene Gentherapie, im Lucile Packard Children's Hospital Stanford eröffnet. ZEVASKYN, das im April 2025 zugelassen wurde, ist die erste und einzige von der FDA zugelassene Therapie zur Behandlung von Wunden bei rezessiver dystropher Epidermolysis bullosa (RDEB) mit nur einer Anwendung.
Die Aktivierung folgt auf eine zehnjährige Forschungszusammenarbeit zwischen Abeona und Stanford Medicine. Die Behandlung ist jetzt sowohl in Stanford als auch im Lurie Children's Hospital in Chicago verfügbar. Um den Patientenzugang zu unterstützen, bietet Abeona Abeona Assist™ an, ein umfassendes Unterstützungsprogramm, das Hilfe bei Versicherungsleistungen, finanzielle Unterstützung und Reiselogistik umfasst.
- First and only FDA-approved therapy for RDEB wounds with single application
- Expansion of treatment availability to second major medical center
- Comprehensive patient support program (Abeona Assist) available for access and financial assistance
- None.
Insights
Abeona's gene therapy ZEVASKYN expanding commercial reach with Stanford site activation, advancing rollout of its FDA-approved RDEB treatment.
Abeona Therapeutics has activated a second Qualified Treatment Center for its groundbreaking ZEVASKYN gene therapy at Lucile Packard Children's Hospital Stanford. This milestone marks significant progress in the commercial rollout following the therapy's FDA approval in April 2025.
The activation of Stanford as a treatment center is particularly meaningful given the decade-long research collaboration between Abeona and Stanford Medicine that led to ZEVASKYN's development. This partnership continuity from research through commercialization demonstrates strong institutional relationships that can facilitate patient access and adoption.
ZEVASKYN represents a first-of-its-kind therapy for recessive dystrophic epidermolysis bullosa (RDEB), a rare and devastating genetic skin disorder. As the only FDA-approved therapy to treat RDEB wounds with a single application, ZEVASKYN has a unique market position with no direct competition currently.
The commercial infrastructure appears well-established, with Abeona implementing a comprehensive patient support program (Abeona Assist™) addressing insurance, financial assistance, and logistics. This approach is critical for rare disease therapies where reimbursement pathways can be complex and patient populations geographically dispersed.
With treatment centers now active in both San Francisco and Chicago, Abeona is establishing a bi-coastal presence that should improve accessibility for patients nationwide. This geographic expansion strategy suggests the company is executing a methodical commercial rollout to ensure proper training and quality control at each treatment site.
- Lucile Packard Children’s Hospital Stanford is ready to accept patients for ZEVASKYN treatment -
- Abeona Therapeutics® and Stanford Medicine conducted research collaboration for more than a decade, culminating in U.S. Food and Drug Administration (FDA) approval of ZEVASKYN in April 2025 -
- ZEVASKYN is the only FDA-approved therapy to treat RDEB wounds with a single application -
CLEVELAND, July 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced activation of the newest Qualified Treatment Center (QTC) for FDA-approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets. This first-of-its-kind therapy, an outcome of a decade of research by Abeona and two decades of research at Stanford Medicine, where the technology originated, will be used to treat wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). Lucile Packard Children’s Hospital Stanford has completed QTC start-up activities and is now ready to accept patients for treatment with ZEVASKYN.
“We're thrilled to announce the availability of ZEVASKYN treatment at Lucile Packard Children’s Hospital Stanford and to continue our long-standing collaboration with Stanford Medicine,” said Dr. Madhav Vasanthavada, Chief Commercial Officer of Abeona. “This site activation is a key milestone in our commercial launch, and we are excited that RDEB patients can now access ZEVASKYN at both Lucile Packard Children’s Hospital Stanford and Lurie Children’s Hospital of Chicago.”
Joyce Teng, MD, PhD, professor of dermatology at Stanford University and pediatric dermatologist at Stanford Medicine Children’s Health, said, “This treatment offers profound new hope for patients and families battling this life-altering, painful skin disorder. This milestone is a powerful testament to the patients participating in clinical trials, and the tireless dedication of Stanford Medicine’s scientists and medical professionals who pioneered this research. This represents a scientific triumph and a profound step toward improving quality of life for so many.”
Abeona is committed to enabling access to ZEVASKYN for eligible patients in the U.S. and has deployed services to provide information and resources to make informed decisions about treatment with ZEVASKYN for RDEB wounds. Abeona’s comprehensive patient support program, Abeona Assist™, offers personalized support, including helping patients understand their insurance benefits and financial assistance options, and providing travel and logistical assistance. For more information on how to access ZEVASKYN and learn about patient support services offered through Abeona Assist, visit www.abeonaassist.com, call 1-855-ABEONA-1 (1-855-223-6621) or email MyNavigator@AbeonaAssist.com.
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 cGMP cell and gene therapy 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 to improve tropism profiles 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 commercialize ZEVASKYN, 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 from the FDA or other regulatory agencies, including those relating to preclinical programs; the ability to achieve or obtain necessary regulatory approvals; the impact of any changes in the financial markets and global economic conditions; 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 the 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.
Investor and Media Contact: Greg Gin VP, Investor Relations and Corporate Communications Abeona Therapeutics ir@abeonatherapeutics.com
FAQ
What is ZEVASKYN and when was it approved by the FDA?
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