From Nasdaq: 2025-06-13 23:55:00

KalVista Pharmaceuticals Inc. announced that the FDA will not meet the PDUFA goal date for the NDA for sebetralstat, an oral on-demand treatment for HAE, due to heavy workload. The FDA expects to deliver a decision within approximately four weeks. No additional data or studies have been requested, and no concerns have been raised about the safety, efficacy, or approvability of sebetralstat. Stay updated on health news at rttnews.com.



Read more at Nasdaq: FDA Delays Decision On KalVista’s Sebetralstat NDA For Hereditary Angioedema