KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet the PDUFA goal date for the New Drug Application (NDA) for sebetralstat, the Company’s investigational oral on-demand treatment for hereditary angioedema (HAE). The FDA notified the Company on June 13, 2025, that the previously disclosed June 17, 2025 PDUFA goal date will not be met d