Abeona Therapeutics Provides Detailed Business Update on ZEVASKYN® Launch Momentum
Abeona Therapeutics Announces Strong Commercial Momentum for ZEVASKYN® Launch
CLEVELAND, March 9, 2026 — Abeona Therapeutics Inc. (Nasdaq: ABEO) has provided a comprehensive business update underscoring the accelerating commercial launch of ZEVASKYN® (prademagene zamikeracel), the first FDA-approved autologous gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare and serious skin disorder.
Key Highlights from the Report
- ZEVASKYN® Launch Momentum: Following the optimization of a critical release assay in 2025, Abeona initiated the commercial launch of ZEVASKYN in Q4 2025, with the first patient successfully treated in December. After a scheduled facility shutdown, manufacturing resumed in late January 2026, and since then, multiple biopsies have been collected, additional patient treatments have occurred, and further manufacturing runs are ongoing. More biopsy collections are planned for the remainder of the quarter.
- Building Treatment Pipeline: Abeona is progressing toward a regular schedule of biopsy collections, gaining improved visibility into the patient funnel for ZEVASKYN. Early experiences are leading to increasing familiarity among Qualified Treatment Centers (QTCs) with the administrative process, and the company is seeing rising interest from both patients and physicians. Initial positive patient outcomes are anticipated to drive sustained demand for ZEVASKYN.
- Strong Market Access and Payer Coverage: All major commercial payers—including United Healthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans—have published coverage policies for ZEVASKYN, collectively representing 80% of lives covered by commercial insurance. ZEVASKYN has also secured coverage across all Medicaid programs.
- Permanent CMS J-code Assignment: The Centers for Medicare & Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN, effective January 1, 2026. This designation is crucial for simplifying the billing and reimbursement process for providers and is a significant milestone in facilitating widespread clinical adoption.
- First-in-Class Therapy: ZEVASKYN is the first and only autologous cell sheet-based gene therapy for RDEB, addressing a high unmet medical need. RDEB patients have a defect in both copies of the COL7A1 gene, resulting in the absence of functional type VII collagen, which causes severe, non-healing skin wounds and life-threatening complications. ZEVASKYN delivers the functional gene into the patient’s own skin cells, enabling production of type VII collagen and promoting wound healing.
- Clinical Benefits: ZEVASKYN has demonstrated meaningful wound healing and pain reduction after a single surgical application in clinical studies.
Potentially Price-Sensitive Information for Shareholders
- Commercial Execution: The company is now seeing tangible patient demand, operational readiness at treatment centers, and growing market acceptance, all of which are critical for revenue ramp and could drive significant changes in near-term and long-term financial performance.
- Payer and Reimbursement Milestones: Achieving broad payer coverage and obtaining a permanent J-code are pivotal for reducing access barriers, accelerating adoption, and ensuring predictable reimbursement. These milestones significantly de-risk the commercial rollout and might positively impact investor sentiment and share price.
- Manufacturing and Supply Chain: The full integration and ongoing operation of Abeona’s cGMP manufacturing facility in Cleveland for ZEVASKYN represents a strategic asset, underlining the company’s ability to scale up as demand grows.
- Risks and Forward-Looking Statements: The update contains forward-looking statements regarding commercial execution, market opportunity, and regulatory matters. Notably, successful commercialization, ongoing payer engagement, manufacturing capacity, and regulatory compliance are all key risk factors that can materially affect future results and share values.
Product and Company Details
- Indication: ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with RDEB.
- Safety Information: Serious allergic reactions, a potential long-term risk of cancer, and theoretical risk of infection transmission (due to use of human and animal materials) are highlighted. Most common side effects are procedural pain and itching. Patients should be monitored for life for cancer risk.
- Corporate Profile: Abeona Therapeutics is a commercial-stage biopharma company with a portfolio including next-generation AAV-based gene therapies for ophthalmic diseases, in addition to its flagship ZEVASKYN therapy.
Investor Relations Contacts
Forward-Looking Statement Disclaimer
This article contains forward-looking statements and is for informational purposes only. Actual results may differ materially due to risks and uncertainties, including but not limited to successful commercialization of ZEVASKYN, manufacturing capacity, regulatory compliance, financial market volatility, and other factors detailed in Abeona’s SEC filings. This is not investment advice. Investors should conduct their own due diligence and consult a financial advisor before making investment decisions.
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