Business
Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates
- Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"- Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adultand pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) - - Entered into sales agreement for priority review voucher (PRV) for $155 million - CLEVELAND, May 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress. “ZEVASKYN's approval just a few weeks ago is a landmark achievement for recessive dystrophic epidermolysis bullosa patients and signifies Abeona's transition to a commercial-stage cell and gene therapy company,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are rapidly advancing the launch of ZEVASKYN and building positive momentum. Patients can now start their treatment journey with Lurie Children's activated as our initial treatment center ready to identify patients and our scheduling system is operational. In addition, we are collecting patient registrations through our patient support program, Abeona Assist™, and have entered into agreements with commercial payer groups ensuring broad access to ZEVASKYN.” Recent Developments ZEVASKYN FDA approval, commercial launch progress and new data FDA approval of first-in-class RDEB therapy: On April 28, 2025, the U.S. FDA approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB. There is no cure for RDEB and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application.Activation of first ZEVASKYN Qualified Treatment Center (QTC): Following approval, ZEVASKYN is now commercially available in the U.S. after the activation of Ann & Robert H. Lurie Children’s Hospital of Chicago, a top-ranked hospital, as the first of five QTCs for ZEVASKYN. The first patient is expected to be treated in the third quarter of 2025. Abeona expects to activate all five QTCs by the end of 2025.High interest from patients and caregivers: Since approval, ap...