The U.S. Food and Drug Administration (FDA) on Monday approved Krystal Biotech, Inc.’s (NASDAQ:KRYS) label update for Vyjuvek (beremagene geperpavec-svdt).
The update expands the Vyjuvek eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek application and managing wound dressings.
Epidermolysis bullosa (EB) is a group of rare, inherited genetic conditions that cause the skin and mucous membranes to be fragile, leading to painful blisters and skin erosions from minor friction or trauma.
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The label update also affords patients greater flexibility in managing wound dressings. Wound dressings are now permitted to be removed as part of the next dressing change rather than waiting 24 hours, further integrating Vyjuvek into existing wound care routines.
The label update is based on real-world data collected since Vyjuvek launch in the U.S., as well as results from the open label extension study conducted in the U.S. and published earlier this year, which collectively reinforce the long-term safety and efficacy of Vyjuvek across patients of all ages, including in cases of patient or caregiver application.
Wall Street welcomed the broader label. In a research note, William Blair wrote, “Vyjuvek’s appealing at-home dosing, its potential to impact patient behavior and quality of life, and the sizable ROW opportunity could all contribute to a strong revenue tail.”
Analyst Sami Corwin reiterated that the company’s current valuation does not reflect the long-term revenue potential of Vyjuvek and catalysts from its clinical pipeline over the next 12 months.
Price Action: KRYS stock is trading higher by 6.01% to $152.32 at last check Monday.
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