Business
Krystal Biotech Announces Third Quarter 2022 Financial Results and Operational Highlights
• Received US FDA filing acceptance of B-VEC BLA with Priority Review designation for treatment of dystrophic epidermolysis bullosa; PDUFA target action date
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"• 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 PITTSBURGH, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today reported financial results and key operational progress updates for the third quarter ended September 30, 2022. “In the third quarter we continued building our commercial footprint in anticipation of a US and an EU launch in 2023, while working closely with the FDA during the review cycle,” said Krish S. Krishnan, Chairman & Chief Executive Officer at Krystal Biotech. “In the next few months, we intend to initiate dosing in our KB407, KB105 and KB301 clinical trials where we have commenced clinical site identification and qualification activities.” Dermatology B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis Bullosa (DEB) In October, following mid-cycle BLA review, the Company was informed that the FDA does not plan on holding an Advisory Committee meeting and has also not identified a need for Risk Evaluation and Mitigation Strategies for the B-VEC application.In September, the Company received a positive opinion from the European Medical Agency (EMA) Pediatric Committee on the Pediatric Investigation Plan for B-VEC for the treatment of DEB with no additional studies required. We are on track to submit a Marketing Authorization Application (MAA) in the fourth quarter of 2022.In August, the FDA accepted and granted Priority Review designation for the B-VEC Biologics License Application (BLA). Rare dermatological pipeline The Company anticipates patient dosing in the ongoing Phase 1/2 clinical trial of KB105 for the treatment of TGM1-...