Core Insights - KalVista Pharmaceuticals' shares have increased by 36% following the FDA's approval of its lead drug, sebetralstat, for hereditary angioedema (HAE) [1][6] - Sebetralstat, marketed as Ekterly, is the first oral on-demand therapy for HAE, marking a significant milestone for KalVista as it transitions into a commercial-stage biotech [2][6] Company Overview - Ekterly is designed for the treatment of acute HAE attacks in individuals aged 12 and older, providing a more convenient alternative to existing injectable treatments [2][5] - The approval of Ekterly allows KalVista to tap into a niche but lucrative market, potentially generating recurring revenue [2] Stock Performance - Year-to-date, KalVista's shares have surged by 89%, significantly outperforming the industry average growth of 5% [3] Treatment Paradigm Shift - Ekterly's oral formulation offers a game-changing advancement in HAE treatment, allowing for timely administration at the onset of symptoms, which is crucial for effective management [5][7] - The drug's safety profile is favorable compared to Takeda's Kalbitor, which has a boxed warning for anaphylaxis, potentially influencing prescribing decisions [8][9] Clinical Data - The FDA approval was supported by data from the KONFIDENT study, which demonstrated that Ekterly provided faster symptom relief and reduced attack severity compared to placebo [9] - KalVista is also conducting a phase III study, KONFIDENT-KID, to evaluate Ekterly in pediatric patients aged 2-11, with results expected later this year [10]