Business
Krystal Biotech Announces First Quarter 2022 Financial Results and Reports Updates on Operational Progress
Biologics License Application for B-VEC remains on track to file in the US in 2Q 2022 and Marketing Authorization in the EU on track to file in 2H 2022FDA
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Biologics License Application for B-VEC remains on track to file in the US in 2Q 2022 and Marketing Authorization in the EU on track to file in 2H 2022FDA allows dosing at a patient’s home in the Open Label Extension Study of B-VEC for the treatment of DEBPositive Clinical Phase 1 (Pearl-1 Study) Efficacy Results for KB301 reported by Jeune Aesthetics, Inc., Krystal Biotech’s subsidiaryStrong balance sheet, closing the quarter with $468.0 million in cash, cash equivalents and investments PITTSBURGH, May 09, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, today reported financial results and key operational progress updates for the first quarter ending March 31, 2022. “Our primary objective in 2022 is to prepare for the potential approval and launch of B-VEC in the U.S.” said Krish S. Krishnan, chairman and chief executive officer. “We also remain focused on our B-VEC global regulatory filings and advancing our robust pipeline and we are fortunate to have a team with unwavering commitment and the financial strength to do so.” Program Highlights & Upcoming Events: B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis Bullosa (“DEB”) On track to file a biologics license application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) in 2Q 2022 and a marketing authorization application with the European Medicines Agency (“EMA”) in 2H 2022.New GEM-3 Phase 3 results for B-VEC were presented at the 2022 American Academy of Dermatology Annual Meeting.Following feedback from the FDA, the Company plans to offer DEB patients enrolled in the GEM-3 open label extension study the ability to be dosed in-home by a health care professional. Further study details are available at www.clinicaltrials.gov under NCT identifier NCT04917887.Results from the Phase 1 and 2 study of B-VEC for the treatment of DEB were published in Nature Medicine which provided a comprehensive analysis of the data showing that repeat topical applications of B-VEC were associated with durable wound closure, full-length cutaneous type VII collagen (COL7) expression, and anchoring fibril assembly with minimal reported adverse events. KB407 for treatment of Cystic Fibrosis (“CF”) Phase 1 clinical trial of inhaled KB407 in patients with CF in Australia is expected to start in 2Q 2022. Details of ...