Krystal Biotech, Inc. (KRYS) Tops Q3 EPS by 2c

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Krystal Biotech Announces Third Quarter 2022 Financial Results and Operational Highlights

November 7, 2022 7:00 AM EST

  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... More