FDA Expands Krystal Biotech Vyjuvek's Label Allowing Newborns Access To Gene Therapy For Blistering Skin

Core Insights - The U.S. FDA approved Krystal Biotech's label update for Vyjuvek, expanding its eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and allowing greater flexibility in wound dressing management [1][3][4] Group 1: Product Update - The label update for Vyjuvek allows for the treatment of DEB patients from birth, enhancing the product's market potential [1] - Patients can now remove wound dressings during the next dressing change instead of waiting 24 hours, integrating Vyjuvek into existing wound care routines [3] Group 2: Clinical Data and Safety - The label update is supported by real-world data collected since Vyjuvek's U.S. launch and results from an open label extension study, confirming the long-term safety and efficacy of Vyjuvek across all ages [4] Group 3: Market Reaction - Wall Street responded positively to the broader label, with analysts noting Vyjuvek's at-home dosing appeal and its potential to improve patient quality of life, which could lead to strong revenue growth [5] - KRYS stock increased by 6.01% to $152.32 following the announcement [6]