Krystal Biotech：FDA批准VYJUVEK标签扩展

FDA批准了一项标签更新，将符合条件的患者群体扩大至包括出生起即患有DEB的患者，并允许患者或护理人员在家自行涂抹VYJUVEK。此变更扩大了获批产品的目标人群，并提高了给药灵活性。

关键事实

申报时间: 2025年11月3日 12:04
事件: FDA 说明书更新
方向: 积极
公司: KRYSKrystal Biotech
资产: beremagene geperpavec-svdt
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 a3q25exhibit991pr.htm EX-99.1 Document Krystal Biotech Announces Third Quarter 2025 Financial and Operating Results $97.8 million in 3Q VYJUVEK revenue and $623.2 million since U.S. launch VYJUVEK launched in Germany in 3Q; launched in France and Japan in 4Q Updated U.S. VYJUVEK label expands eligible patient population and provides greater patient flexibility FDA grants platform technology designation CF interim results expected in 4Q Strong balance sheet, ending the quarter with $864.2 million in cash and investments PITTSBURGH, November 3, 2025 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today reported financial results for the third quarter ending September 30, 2025 and provided a business update. “It is immensely gratifying to see a growing numb

SEC 8-K