by Michael Dabai
Shares of Crystal Biotech Inc. more than doubled in premarket trading after the company said Vyjuvec’s trial for dystrophic epidermolysis bullosa met its primary and secondary objectives.
Dystrophic EB is a rare and serious disease that affects the skin and mucosal tissues. The company said the pivotal GEM-3 trial met its primary endpoint of complete wound healing at the six-month time points and its secondary endpoint of complete wound healing at the three-month time points.
Shares more than doubled, up 123% to $88.96 in premarket trading on Monday.
Crystal said Vyjuvec was well tolerated, with no serious drug-related adverse events or discontinuation.
The company said the biologics license application is on track to be submitted to the US Food and Drug Administration in the first half of 2022.
Crystal said it expects to submit a marketing authorization application in Europe shortly after BLA.
Write to Michael Dabai at [email protected]