FDA Delays Decision On KalVista's Sebetralstat NDA For Hereditary Angioedema

(RTTNews) - KalVista Pharmaceuticals Inc. (KALV) announced Friday now that the U.S. Food and Drug Administration 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 that the previously disclosed June 17, 2025 PDUFA goal date will not be met due to heavy workload and limited resources. The FDA indicated that it expects to deliver a decision within approximately four weeks.

The company noted that the FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat.

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