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Investing.com — Shares of gene therapy company Krystal Biotech Inc (NASDAQ:KRYS) soared 117% on Monday after the announcement of positive data from its trial of a drug to treat a rare skin disease.
The drug, called VYJUVEKTM, is being tested as a potential treatment for dystrophic Epidermolysis Bullosa (dystrophic EB), a rare, severe skin disease. The 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.
Krystal Biotech shares hit a high of $102.99 on the news.
The company’s Founder and CEO Suma Krishnan said Dystrophic Epidermolysis Bullosa is “referred to as ‘the worst disease you’ve never heard of’ because of the incredibly devastating reality that patients with this genetic condition face.”
“We are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEKTM which showed that this topical gene therapy led to durable wound healing in dystrophic EB wounds,” added Krishnan.
The drug was well tolerated. No drug-related serious adverse events or discontinuations were reported.
The company told investors that the biologics license application (BLA) is on track to be submitted to the FDA in H1 2022, while it expects to submit a marketing authorization application in Europe shortly after the BLA.
