Press release
KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Quarter Financial Results
-EKTERLY® now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema- -Initiated US EKTERLY launch in
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n-EKTERLY® now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema-\n\n\n-Initiated US EKTERLY launch in July; received 460 patient start forms through August-\n\n\n-European Medicines Agency adopted a positive opinion recommending approval of sebetralstat and confirmed maintenance of orphan designation in EU; decision expected early October-\n\n\n-$191M in cash, providing runway into 2027-\n\n\n-Management to host conference call today at 8:30 a.m. ET-\n\n\n FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided an operational update and released financial results for the fiscal quarter ended July 31, 2025.\n\n\n“This quarter marked a defining moment in the history of KalVista with the FDA approval of EKTERLY—the first and only oral on-demand treatment for HAE,” stated Ben Palleiko, CEO of KalVista. “Approval and launch on the same day propelled us immediately into our next chapter of growth as a commercial company, and the response has been extraordinary. In just eight weeks following approval, we have received 460 patient start forms, representing almost five percent of the reported HAE patient population in the US. This early demand has exceeded our expectations, validating both the urgent unmet need that EKTERLY addresses and its potential to redefine management of HAE. Backed by a strong balance sheet and a world-class team, we are well positioned to maximize the global opportunity for EKTERLY to become the foundational therapy for people living with HAE.”\n\n\nRecent Business Highlights\n\n\nEKTERLY® (sebetralstat)\n\n\n\nOn July 7, 2025, KalVista announced FDA approval of EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.\n\n\n\nInitiated US commercial launch on July 7, 2025 and received 460 patient start forms for the period ended August 29, 2025.\n\n\n\nIn July 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) granted marketing authorization for EKTERLY (sebetralstat). EKTERLY also met the requirements of the MHRA Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit ...