Market PositionThe efficacy and long-term durability of prademagene zamikeracel, along with the high list price of a competing product, should enable Abeona to outcompete Filsuvez in the RDEB population.
Medicare ReimbursementFavorable Medicare reimbursement decisions should streamline logistics for prademagene zamikeracel market uptake post-approval.
Regulatory ApprovalAbeona's Biologics License Application for its lead candidate, prademagene zamikeracel, has been accepted by the FDA for review, with an approval decision date set for April 29, 2025.