Posted by Michael Wonder on 16 Jun 2025
KalVista Pharmaceuticals announces FDA will not meet PDUFA goal date for sebetralstat NDA for hereditary angioedema due to FDA resource constraints
13 June 2025 - Agency indicates anticipated decision within four weeks
KalVista Pharmaceuticals today announced that the US FDA has notified the Company that it will not meet the PDUFA goal date for the new drug application for sebetralstat, the Company’s investigational oral on-demand treatment for hereditary angioedema. The FDA notified the Company on 13 June 2025, that the previously disclosed 17 June 2025 PDUFA goal date will not be met due to heavy workload and limited resources.
