KalVista Pharmaceuticals received FDA approval for Ekterly (sebetralstat), the first oral on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 and older. This approval follows a regulatory delay attributed to FDA resource constraints rather than safety or efficacy concerns. Ekterly demonstrated rapid symptom relief within a median of 1.3 hours and offers a dosing advantage compared to existing injectable therapies such as Firazyr. Analysts project peak U.S. sales could reach $600 million annually. Additionally, KalVista has engaged commercial partners in Canada and Japan to manage regulatory approval and commercialization.