KalVista Pharmaceuticals, Inc. has announced a delay in the regulatory review process for sebetralstat, its investigational oral on-demand treatment for hereditary angioedema $(HAE)$, due to the U.S. Food and Drug Administration (FDA) facing a heavy workload and limited resources. The FDA informed KalVista on June 13, 2025, that it will not meet the previously set Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025. However, the FDA anticipates reaching a decision within approximately four weeks. KalVista has expressed disappointment over the delay but remains confident in the near-term approval of sebetralstat, emphasizing their ongoing commitment to bringing this important therapy to people living with HAE. There is no mention of any grant or funding being obtained by KalVista or any other organizations in relation to this announcement.
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