Received US FDA filing acceptance of B-VEC BLA with Priority Review designation for treatment of dystrophic epidermolysis bullosa; PDUFA target action date of February 17, 2023
• Notified of no Advisory Committee meeting or a need for Risk Evaluation and Mitigation Strategies following mid-cycle BLA review for the B-VEC application
• Received positive opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for treatment of dystrophic epidermolysis bullosa; on track to submit a marketing authorization application in fourth quarter of 2022
• Strong balance sheet, closing the quarter with $407.0 million in cash, cash equivalents and investments
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