Abeona Therapeutics® Announces Permanent J-Code for ZEVASKYN® (prademagene zamikeracel)
Abeona Therapeutics (Nasdaq: ABEO) announced that the Centers for Medicare and Medicaid Services has established a permanent HCPCS J-code J3389 for ZEVASKYN (prademagene zamikeracel), its autologous gene‑modified cellular sheet for wounds in adult and pediatric recessive dystrophic epidermolysis bullosa (RDEB).
The J-code, defined as “Topical administration, prademagene zamikeracel, per treatment,” becomes effective January 1, 2026. Abeona said the product‑specific code will simplify claims and reimbursement, support hospital adoption, and improve patient access across public and private payers.
Abeona Therapeutics (Nasdaq: ABEO) ha annunciato che i Centers for Medicare and Medicaid Services hanno istituito un codice HCPCS J-code J3389 permanente per ZEVASKYN (prademagene zamikeracel), il suo strato cellulare modificato geneticamente autologo per ferite in adulti e bambini affetti da epidermolisi bollosa recessiva (RDEB).
Il codice J, definito come “somministrazione topica, prademagene zamikeracel, per trattamento”, entrerà in vigore 1 gennaio 2026. Abeona ha dichiarato che il codice specifico per il prodotto semplificherà i reclami e i rimborsi, sosterrà l’adozione ospedaliera e migliorerà l’accesso dei pazienti tra assicurazioni pubbliche e private.
Abeona Therapeutics (Nasdaq: ABEO) anunció que los Centers for Medicare and Medicaid Services han establecido un código HCPCS J-code J3389 permanente para ZEVASKYN (prademagene zamikeracel), su hoja celular modificada genéticamente autóloga para heridas en adultos y niños con epidermólisis bullosa distrófica recesiva (RDEB).
El código J, definido como “administración tópica, prademagene zamikeracel, por tratamiento”, entrará en vigor el 1 de enero de 2026. Abeona dijo que el código específico del producto simplificará las reclamaciones y reembolsos, apoyará la adopción en hospitales y mejorará el acceso de los pacientes ante aseguradoras públicas y privadas.
에이보나 테라퓨틱스(Nasdaq: ABEO)는 CMS가 성인 및 소아 재발성 확산성 표피박리성 혈관질환(RDEB) 환자의 상처를 위한 자가 유전자 수정 세포 시트인 ZEVASKYN(prademagene zamikeracel)에 대해 영구 HCPCS J-code J3389를 제정했다고 발표했습니다.
J-code는 “처치당 국소 투여, prademagene zamikeracel, 치료당”으로 정의되며 2026년 1월 1일부로 발효됩니다. Abeona는 제품별 코드가 청구 및 환급을 단순화하고 병원 채택을 지원하며 공적·민간 보험자 전반에 걸친 환자 접근성을 개선할 것이라고 밝혔습니다.
Abeona Therapeutics (Nasdaq : ABEO) a annoncé que les Centers for Medicare and Medicaid Services ont établi un code HCPCS J-code J3389 permanent pour ZEVASKYN (prademagene zamikeracel), son feuillet cellulaire modifié génétiquement autologue pour les plaies chez les adultes et les enfants atteints de dermatite bulleuse dystrophique récessive (RDEB).
Le code J, défini comme « administration topique, prademagene zamikeracel, par traitement », entrera en vigueur le 1er janvier 2026. Abeona a déclaré que ce code spécifique au produit simplifiera les réclamations et le remboursement, soutiendra l’adoption hospitalière et améliorera l’accès des patients auprès des assureurs publics et privés.
Abeona Therapeutics (Nasdaq: ABEO) kündigte an, dass die Centers for Medicare and Medicaid Services einen dauerhaften HCPCS-J-Code J3389 für ZEVASKYN (prademagene zamikeracel), sein autologes, genetisch verändertes zelluläres Blatt für Wunden bei Erwachsenen und pädiatrischen Patienten mit rezessiver dystropher Epidermolysis bullosa (RDEB), eingeführt haben.
Der J-Code, definiert als „Topische Gabe, prademagene zamikeracel, pro Behandlung“, tritt am 1. Januar 2026 in Kraft. Abeona sagte, der produktspezifische Code werde Ansprüche und Erstattungen vereinfachen, die Einführung in Krankenhäusern unterstützen und den Zugang der Patienten über öffentliche und private Kostenträger verbessern.
Abeona Therapeutics (نازداك: ABEO) أعلنت أن مراكز خدمات التأمين الطبي (CMS) قد أنشأت رمز HCPCS-J دائم J3389 لـ ZEVASKYN (prademagene zamikeracel)، لوحيها الخلوي المعدل جينياً ذاتياً للجروح عند البالغين والأطفال المصابين بمرض epidermolysis bullosa dystrophica recessive (RDEB).
يُعرَّف الرمز J بأنه «الإعطاء الموضعي، prademagene zamikeracel، لكل علاج»، وسيصبح ساري المفعول في 1 يناير 2026. قالت Abeona إن الرمز الخاص بالمنتج سيبسّط المطالَبات والتعويضات، سيدعم اعتماد المستشفيات، وسيحسن وصول المرضى إلى التأمينات العامة والخاصة.
- Permanent HCPCS J-code J3389 assigned for ZEVASKYN
- J-code effective January 1, 2026
- Simplifies claims and reimbursement processing with payers
- Supports hospital adoption and patient access for ZEVASKYN
- None.
CLEVELAND, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, the Company’s autologous gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The new J-code for ZEVASKYN, J3389 (Topical administration, prademagene zamikeracel, per treatment) becomes effective on January 1, 2026.
"The assignment of a unique, product-specific J-code by CMS is a major step forward in ZEVASKYN’s launch," said Dr. Madhav Vasanthavada, Chief Commercial Officer of Abeona. "This code will simplify claims and reimbursement processing between our qualified treatment centers and payers across public and private sectors, and further support hospital adoption and patient access for ZEVASKYN."
J-codes are unique identifiers designed to identify non-orally administered medications in healthcare settings. A J-code plays a vital role in streamlining the medical billing and reimbursement processes related to drug administration.
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 gene modified cellular sheets are made by inserting the correct COL7A1 gene into a patient’s own skin cells ex vivo using a replication-incompetent retroviral vector, resulting in functional type VII collagen expression 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 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 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; 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 is the new HCPCS J-code for ZEVASKYN (ABEO) and when is it effective?
How will J-code J3389 affect reimbursement for ZEVASKYN (ABEO)?
Which patients is ZEVASKYN (ABEO) indicated for under the J-code assignment?
Will the J-code J3389 help hospital adoption of ZEVASKYN (ABEO)?
What does J3389 describe for ZEVASKYN (ABEO)?
