Business
Krystal Biotech Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress
• B-VEC PDUFA date May 19, 2023 • Data from the pivotal Phase 3 (GEM-3) trial of B-VEC for dystrophic epidermolysis bullosa published in the New England
About this update from Krystal Biotech, Inc.
[{"type":"text","content":" • B-VEC PDUFA date May 19, 2023 • Data from the pivotal Phase 3 (GEM-3) trial of B-VEC for dystrophic epidermolysis bullosa published in the New England Journal of Medicine • Four pipeline clinical trials in dermatology, respiratory and aesthetics to initiate in 2023 • Strong balance sheet, closing the quarter with $383.8 million in cash, cash equivalents and investments PITTSBURGH, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines, today reported financial results and key operational updates for the fourth quarter and year ending December 31, 2022. “In 2022, we were focused on advancing B-VEC toward approval and getting commercially prepared for a potential launch this year, and I thank the entire Krystal team for their dedication and perseverance in helping us achieve our objectives,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech, Inc. He added, “Our focus in 2023 will be on advancing our pipeline and demonstrating the breadth of our gene delivery platform. We plan to have ASTRA, our second manufacturing facility, operational early this year which will enable us to advance our pipeline products in a timely manner.” Dermatology B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis Bullosa (DEB) On January 5, 2023, the Company was notified by the U.S. Food & Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) date for the Company’s Biologics License Application (BLA) for B-VEC for the treatment of patients with DEB, will be May 19, 2023 and that proposed labeling discussions would begin no later than April 20, 2023. All clinical and manufacturing inspections conducted by the FDA as part of the BLA review process are now successfully complete.In December 2022, the results of the B-VEC pivotal Phase 3 GEM-3 trial were published in the New England Journal of Medicine (NEJM). The GEM-3 trial was a randomized, double-blind, intra-patient, placebo-controlled, multi-center study designed to evaluate the efficacy and safety of B-VEC for the treatment of DEB. Two editorials were also published in the same issue of NEJM on the GEM-3 trial.The Company submitted a request for Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in November 2022 for ...