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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.