Press release
KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints
FDA states heavy workload and limited resources prevent meeting PDUFA goal date of June 17 Agency indicates anticipated decision within four weeks CAMBRIDGE,
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nFDA states heavy workload and limited resources prevent meeting PDUFA goal date of June 17\n\n\nAgency indicates anticipated decision within four weeks\n\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) 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 on June 13, 2025, 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.\n\n\nThe FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat. KalVista has addressed all prior information requests in a timely manner, and the Company believes the only remaining item under FDA review is the finalization of the labelling.\n\n\n“We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks,” said Ben Palleiko, CEO of KalVista. “At the same time, we remain confident in the near-term approval of sebetralstat. We are continuing to work closely with the FDA to support the completion of their review. Our commitment to bringing this important therapy to people living with HAE remains unwavering.”\n\n\nAbout Sebetralstat\n\n\nSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.\n\n\nAbout Hereditary Angioedema\n\n\nHereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experi...