KalVista Pharmaceuticals reports second fiscal quarter results and operational update
KalVista Pharmaceuticals provided an operational update and released financial results for the second fiscal quarter ended 31 October 2023.
Andrew Crockett, Chief Executive Officer of KalVista, said: “We are in the process of completing the KONFIDENT trial and we look forward to advancing sebetralstat for an NDA submission in the first half of 2024. As we plan on several regulatory filings in the coming year, we are also continuing to build out our commercial organization in order to support a rapid launch upon FDA approval.”
Second Fiscal Quarter and Recent Business Highlights:
- Achieved the number of on-treatment attacks required to complete the phase 3 KONFIDENT trial. Topline data readout is expected in early 2024, remaining on track for a New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) in the first half of 2024. The Company also expects to file for approval in the European Union and Japan later in 2024
- Received Orphan Drug Status (ODS) approval from Switzerland for sebetralstat, allowing for shorter review time, priority authorization, and 15 years market protection and exclusivity
- Presented real-world patient data at the 2023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology discussing compliance challenges of currently available parenteral on-demand HAE treatments and evidence of the global prevalence of normal C1-inhibitor HAE (HAE-nC1-INH)
- Reported data at the Asia Pacific Association of Allergy, Asthma and Clinical Immunology 2023 International Conference characterizing HAE attacks in patients receiving long-term prophylaxis (LTP)
(Source: KalVista)
