Abeona Launches ZEVASKYN, Secures 80% Commercial Coverage and HCPCS J-code
FDA-approved ZEVASKYN launch began in Q4 2025, with first patient treated in December and manufacturing resumed in January, yielding multiple biopsies and ongoing runs. Coverage secured from major commercial payers covering 80% of lives and all Medicaid plans, and CMS established permanent HCPCS J-code J3389 to streamline reimbursement.
1. ZEVASKYN Commercial Launch Momentum
Abeona initiated ZEVASKYN's commercial launch in Q4 2025, performing its first patient treatment in December. Manufacturing resumed in late January 2026, with multiple biopsies collected, one patient completing the therapy and additional manufacturing runs ongoing this quarter.
2. Broad Payer Coverage and J-code Assignment
All major commercial insurers covering 80% of commercially insured lives have published coverage policies for ZEVASKYN, complemented by coverage across all Medicaid programs. CMS established permanent HCPCS J-code J3389 effective January 1, 2026, to simplify medical billing and reimbursement.
3. Provider Engagement and Patient Funnel Growth
Initial Qualified Treatment Centers are adapting to the administrative process and increasing patient and physician interest in ZEVASKYN. Abeona expects these early positive patient experiences to drive sustained demand and expand the treatment funnel.