KalVista Pharmaceuticals won FDA approval for Ekterly (sebetralstat), the first oral on-demand therapy for hereditary angioedema (HAE) attacks in patients aged 12 and older. The approval follows a delay attributed to agency resource constraints but included no safety or efficacy concerns. Ekterly provides symptom relief within approximately two hours and offers flexible dosing allowing a second dose within three hours, presenting a competitive advantage over existing injectable treatments. The oral drug is positioned to capture significant market share in the rare disease space with peak US sales estimated at $600 million. Licensing agreements for its commercialization in Canada and Japan are underway.