Core Points - Abeona Therapeutics Inc. has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million upon closing of the transaction [1] - The PRV was awarded following the FDA approval of ZEVASKYN™ (prademagene zamikeracel) on April 28, 2025 [1] - Proceeds from the PRV sale will provide sufficient cash for more than two years of operating expenses without the need for additional capital, excluding ZEVASKYN sales [2] - ZEVASKYN is expected to be available for patient treatment starting in the third quarter of 2025, with profitability anticipated in early 2026 [2] - The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott Rodino Antitrust Improvements Act [2] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [4] - ZEVASKYN is the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [4] - The company operates a fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio, which serves as the production site for ZEVASKYN [4] - Abeona's development portfolio includes adeno-associated virus (AAV)-based gene therapies targeting ophthalmic diseases with high unmet medical needs [4]
Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million