Krystal Biotech, Inc. (NASDAQ: KRYS) is engaged as a gene therapeutics company, which is focused on the research, development and testing of novel therapies using its redosable gene therapy platform and in-house manufacturing capabilities. Shares of the gene therapeutics company are skyrocketing 118% through early trading on Monday, November 29, 2021. Over the past three months, Krystal Biotech has seen average daily volume of 155,010 shares. However, volume of 4.73 million shares or dollar volume of $412.98 million, has already exchanged hands through early trading Monday.
Shares of Krystal Biotech are surging Monday, after the company announced positive topline results from its pivotal GEM-3 trial of its VYJUVEK candidate for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB). VYJUVEK is the first non-invasive, topical and redosable gene therapy and the only treatment to take a “genetically corrective” approach to treatment.
The primary endpoint of the trial was to evaluate wound healing using topical VYJUVEK compared to a placebo. Over a six-month period, VYJUVEK’s performance compared to the placebo group showed statistical significance.
Overall, 31 patients were enrolled into the clinical trial. Around 67% of enrolled patients treated with VYJUVEK achieved the primary endpoint of complete wound healing at the six-month mark. This compares to only 22% in the placebo group.
On a secondary endpoint basis, 71% of patients treated with the candidate saw complete wound healing at the three-month point. This compares to only 20% in the placebo group. VYJUVEK was well-tolerated and did not cause any serious drug-related side effects. One mild adverse event was report during the clinical trial.
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, and 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,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal. “With these results in hand, we look forward to advancing discussions with regulatory authorities and will work quickly to bring this potential first-ever treatment to patients with dystrophic EB and their families who are in desperate need.”
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