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Stock impact report

KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema

KalVista Pharmaceuticals, Inc. (KALV) 
Last kalvista pharmaceuticals, inc. earnings: 3/10 07:30 am Check Earnings Report
US:NASDAQ Investor Relations: ir.kalvista.com
Company Research Source: Business Wire
–Orphan drug designation paves the way for potential of sebetralstat to be first oral on-demand treatment for HAE in Japan–– Submission advances Company’s strategic plan to address unmet needs in HAE on global scale– CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted sebetralstat Orphan Drug Designation. The Company has also submitted a New Drug Application (NDA) for sebetralstat to the Agency. If approved, sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older, would be the first oral on-demand treatment for HAE in Japan.“The submission of our NDA for sebetralstat in Japan represents another key step toward our efforts to make this important new treatment available to as many people living with HAE as possible,” Show less Read more
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