FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE approved in Japan. EKT. ...

Core Insights - KalVista Pharmaceuticals reported strong momentum in the US launch of EKTERLY®, achieving $13.7 million in net product revenue for the third quarter of 2025, with 937 patient start forms received by October 31, 2025 [1][3][9] - The company has successfully launched EKTERLY in Germany, with initial orders indicating positive demand, and has received regulatory approval in Australia, expanding its global footprint [2][3] - As of September 30, 2025, KalVista has approximately $309 million in cash, expected to fund operations until profitability [1][9] Commercial Progress - The US commercial launch of EKTERLY began on July 7, 2025, with 423 unique prescribers activated [3] - EKTERLY is the first and only oral on-demand treatment for hereditary angioedema (HAE) approved in the US, EU, Switzerland, and Australia [6][9] - The European Commission and Swissmedic approved EKTERLY for treating acute HAE attacks in adults and adolescents aged 12 and older [3] Financial Performance - For the three months ended September 30, 2025, KalVista reported a net product revenue of $13.7 million, with a cost of revenue of $1.2 million [9][12] - Research and development expenses decreased to $12 million from $18.7 million in the same period of 2024, primarily due to reduced clinical trial costs [9][12] - Selling, general and administrative expenses increased to $46.5 million from $24.8 million, attributed to commercialization efforts for EKTERLY [9][12] Organizational Updates - The company appointed Bilal Arif as Chief Operating Officer and Linea Aspesi as Chief People Officer [9] - Bethany L. Sensenig joined KalVista's Board of Directors and the Audit Committee [9] Clinical Highlights - Interim results from the KONFIDENT-KID trial showed a median time to dosing of 30 minutes and a median time to symptom relief of 1.5 hours for pediatric patients [9] - In the KONFIDENT-S trial, 84% of treated attacks were rated as satisfied by patients who switched from injectable treatments [9]

Core Viewpoint - KalVista Pharmaceuticals has received approval from the European Commission and Swissmedic for EKTERLY (sebetralstat), marking it as the first oral on-demand treatment for hereditary angioedema in Europe [1] Company Summary - KalVista Pharmaceuticals, Inc. is focused on developing treatments for rare diseases, specifically targeting hereditary angioedema with its new product EKTERLY [1] - The approval of EKTERLY is significant as it provides a new therapeutic option for adults and adolescents aged 12 years and older suffering from acute attacks of hereditary angioedema [1] Industry Summary - The approval of EKTERLY highlights advancements in the treatment options available for hereditary angioedema, a condition that has limited treatment alternatives [1] - The introduction of an oral plasma kallikrein inhibitor like EKTERLY may shift treatment paradigms within the rare disease market, particularly for hereditary angioedema [1]

Core Viewpoint - KalVista Pharmaceuticals has received approval from the European Commission and Swissmedic for EKTERLY (sebetralstat), marking it as the first and only oral on-demand treatment for hereditary angioedema (HAE) in Europe [1] Company Summary - KalVista Pharmaceuticals, Inc. is focused on developing innovative treatments for rare diseases, specifically targeting hereditary angioedema with its new product EKTERLY [1] - The approval of EKTERLY is significant as it provides a new therapeutic option for adults and adolescents aged 12 years and older suffering from acute attacks of HAE [1] Industry Summary - The approval of EKTERLY highlights advancements in the treatment of hereditary angioedema, a condition that has limited treatment options available [1] - The introduction of an oral plasma kallikrein inhibitor represents a shift in the management of HAE, potentially improving patient compliance and outcomes [1]