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Krystal Biotech Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Update on Operational Progress
Following successful completion of GEM-3 pivotal trial, Krystal is on track to file BLA for Vyjuvek™ for the treatment of dystrophic epidermolysis bullosa in
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Following successful completion of GEM-3 pivotal trial, Krystal is on track to file BLA for Vyjuvek™ for the treatment of dystrophic epidermolysis bullosa in 1H 2022; MAA filing anticipated in 2H 2022Phase 1 trial of KB407 in cystic fibrosis patients in Australia expected to begin in 1H 2022; IND filing and U.S. trial initiation anticipated in 2H 2022Jeune Aesthetics on track to announce Phase 1 proof-of-concept efficacy data from KB301, being developed for aesthetic indications, in 1Q 2022Strong balance sheet with December 31, 2021 cash, cash equivalents and investments of $502.5 million PITTSBURGH, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal” or the \"Company\") (NASDAQ: KRYS), the leader in redosable gene therapy, today reported financial results and key operational updates for the fourth quarter and year ending December 31, 2021. “I would like to thank the entire Krystal team for their dedication in 2021. This was an important year for Krystal with the announcement of positive topline data from the Phase 3 trial of VyjuvekTM for the treatment of dystrophic epidermolysis bullosa. We are now working diligently toward global regulatory filings, including submitting our biologics license application, and preparing for commercialization,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech, Inc. He added, “The positive Phase 3 data provides strong validation of our approach and our platform as we advance new medicines to treat other debilitating diseases.” Fourth Quarter Program Highlights & Upcoming Events: Vyjuvek for the treatment of Dystrophic Epidermolysis Bullosa (EB) In November 2021, the Company announced positive topline data from the pivotal GEM-3 trial of topical Vyjuvek (beremagene geperpavec or B-VEC) for the treatment of dystrophic EB. The Company intends to present more detailed results at upcoming medical congresses.The Company is on track to file a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in 1H 2022 and a marketing authorization application with the European Medicines Agency (EMA) in 2H 2022. KB407 for the treatment of Cystic Fibrosis (CF) The Company expects to initiate a Phase 1 clinical trial of inhaled KB407 in patients with CF in Australia in 1H 2022. Details of the Phase 1 study can be found at www.clinicaltrials.gov under NCT identif...