KalVista Pharmaceuticals

KalVista Pharmaceuticals, Inc. is a global biopharmaceutical company founded in 2011, with headquarters in Cambridge, MA, and a significant presence in Salisbury, UK. The company specializes in the discovery, development, and commercialization of oral, small-molecule protease inhibitors for diseases with significant unmet needs. A primary focus is on the kallikrein-kinin system (KKS) to create treatments for rare diseases such as hereditary angioedema (HAE) and formerly, diabetic macular edema (DME). One of the company's scientific co-founders is Edward P. Feener, Ph.D., a recognized authority on plasma kallikrein and its role in vascular disorders, who later became the Chief Scientific Officer.

KalVista's lead product, EKTERLY® (sebetralstat), is a novel plasma kallikrein inhibitor and the first and only oral, on-demand treatment approved by the U.S. Food and Drug Administration (FDA) for acute attacks of HAE in patients 12 years and older. This approval, granted in July 2025, represents a significant milestone, offering an alternative to injectable therapies and allowing patients to treat attacks as symptoms begin. The approval was based on data from the large-scale Phase 3 KONFIDENT clinical trial. The company is also developing an orally disintegrating tablet (ODT) formulation of sebetralstat, particularly for pediatric patients, and is exploring an oral Factor XIIa inhibitor for HAE prophylaxis.

As a clinical-stage company, KalVista's business model is rooted in the biotechnology sector, characterized by substantial investment in research and development. Historically, the company did not generate revenue from product sales, relying on licensing agreements and collaborations. With the approval of EKTERLY®, the company is transitioning to commercialization, building out its sales infrastructure and pursuing global regulatory approvals in Europe, the UK, and Japan. KalVista's revenue model will shift to include direct product sales, milestone payments, and royalties from partnerships, such as its agreement with Kaken Pharmaceutical, Co., Ltd. for commercialization in Japan.

Keywords: oral therapies, rare diseases, protease inhibitors, hereditary angioedema, HAE, sebetralstat, EKTERLY, plasma kallikrein inhibitor, small molecule drugs, clinical-stage pharmaceutical, Factor XIIa inhibitor, on-demand treatment, biopharmaceutical, kallikrein-kinin system, KONFIDENT trial, drug development, vascular permeability, orphan drugs, Cambridge, Salisbury