Krystal Biotech Q4 2021 Earnings Report
Key Takeaways
Krystal Biotech reported positive topline data from the Phase 3 trial of VyjuvekTM for the treatment of dystrophic epidermolysis bullosa and is working towards global regulatory filings. The company's cash, cash equivalents and investments totaled $502.5 million on December 31, 2021.
Announced positive topline data from the pivotal GEM-3 trial of topical Vyjuvek for the treatment of dystrophic EB.
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.
Expects to initiate a Phase 1 clinical trial of inhaled KB407 in patients with CF in Australia in 1H 2022 and plans to expand the Phase 1 trial clinical program to the U.S. in 2H 2022.
Jeune Aesthetics expects to announce safety and proof-of-concept efficacy data from the Phase 1 study of intradermal KB301 in 1Q 2022.