By Michael Dabaie
Krystal Biotech Inc. shares more than doubled in premarket trading after the company said a trial of Vyjuvek for dystrophic epidermolysis bullosa met its primary and secondary objectives.
Dystrophic EB is a rare and severe disease that affects the skin and mucosal tissues. The pivotal GEM-3 trial met its primary endpoint of complete wound healing at six-month timepoints, and its secondary endpoint of complete wound healing at three-month timepoints, the company said.
Shares more than doubled, up 123% to $88.96 in premarket trading Monday.
Vyjuvek was well tolerated, with no drug-related serious adverse events or discontinuations, Krystal said.
The company said the biologics license application is on track to be submitted to U.S. Food and Drug Administration in the first half of 2022.
Krystal said it expects to submit a marketing authorization application in Europe shortly after the BLA.
Write to Michael Dabaie at email@example.com
(END) Dow Jones Newswires