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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。