KalVista Pharmaceuticals announced that the Japanese Ministry of Health, Labor and Welfare has granted marketing and manufacturing approval for its oral on‑demand hereditary angioedema (HAE) therapy, EKTERLY (sebetralstat), for adults and adolescents 12 years and older. The approval, issued on December 22 2025, makes EKTERLY the first and only oral on‑demand treatment for HAE approved in Japan and represents a key milestone in the company’s global launch strategy.
EKTERLY is a small‑molecule, oral therapy that provides rapid relief of HAE attacks. The approval is supported by data from the Phase 3 KONFIDENT trial, which enrolled 136 patients across 66 sites in 20 countries and demonstrated faster symptom relief and reduced attack severity compared with placebo. KalVista will commercialize the product in Japan through its partner Kaken Pharmaceutical Co., Ltd., which will handle distribution and listing on the Japanese National Health Insurance System.
The Japanese approval expands KalVista’s commercial footprint and accelerates revenue growth in a new market. It is the seventh major market authorization for EKTERLY since the U.S. approval in July 2025, and it complements existing approvals in the U.K., EU, Switzerland, Australia, and Singapore. The company’s Q3 2025 earnings showed a revenue beat—$13.69 million versus the $7.17 million consensus—driven by strong demand in the U.S. and European markets, while SG&A expenses rose due to increased commercialization spend for EKTERLY.
KalVista’s CEO Ben Palleiko emphasized that the Japan approval “marks another major milestone in our global pursuit to bring the first and only oral on‑demand treatment to people living with HAE.” The company remains focused on scaling EKTERLY worldwide, with ongoing pediatric studies and a strategy to leverage its partnership network to accelerate market entry in other regions.
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