Press release
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
– Submitted NDA for sebetralstat as first-ever, oral on-demand treatment for HAE attacks, a pivotal moment for the HAE community – – Potential FDA approval
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Submitted NDA for sebetralstat as first-ever, oral on-demand treatment for HAE attacks, a pivotal moment for the HAE community –\n\n\n– Potential FDA approval and launch of sebetralstat in first half 2025 -\n\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2024.\n\n\n“This last fiscal quarter was the most important in the history of KalVista,” said Ben Palleiko, CEO of KalVista. “Not only did we submit the NDA for sebetralstat to the FDA, but the KONFIDENT phase 3 trial results were published in The New England Journal of Medicine, supporting our view on the importance of this potential therapy. We look forward to building on these milestones as we submit additional marketing authorization applications to other national health authorities throughout 2024 and anticipate approval and launch in the US in the first half of 2025.”\n\n\nFiscal 2024 and Recent Business Highlights:\n\n\nSebetralstat\n\n\n\nIn June 2024, KalVista submitted a New Drug Application (NDA) for U.S. Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.\n\n\n\nAlso in June, the Company initiated ahead of schedule a pediatric clinical trial (KONFIDENT-KID) using an orally disintegrating tablet (ODT) formulation of sebetralstat designed for this population. KONFIDENT-KID will enroll approximately 24 children, with an age range of 2 to 11 years, across seven countries in North America, Europe and Asia. If approved, sebetralstat would be the first oral, on demand treatment for this population and only the second approved on-demand therapy of any type.\n\n\n\nData from phase 3 KONFIDENT trial of sebetralstat was published in the New England Journal of Medicine (NEJM) and presented concurrently at the European Academy of Allergy and Clinical Immunology Congress 2024 (EAACI).\n\n\n\nPresented the U.S. subgroup analysis from the phase 3 KONFIDENT trial at the Eastern Allergy Conference (EAC) 2024, as well as the Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the Japanese Dermatological Association (JDA) 2024.\n\n...