Krystal Biotech, Inc. (NASDAQ:KRYS) submits biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of B-VEC (beremagene geperpavec) in the treatment of patients with dystrophic epidermolysis bullosa (DEB).
The BLA submission for B-VEC is supported by data readout from the GEM-3, a multi centre trial and the GEM-1/2, a single-center trial, designed to evaluate the efficacy and safety of B-VEC for the treatment of DEB.
