KalVista Pharmaceuticals secured FDA approval for Ekterly (sebetralstat), the first oral on-demand therapy to treat acute hereditary angioedema (HAE) attacks in patients aged 12 and older. The approval follows a brief FDA review delay attributed to resource limitations but without safety or efficacy concerns. Ekterly offers symptom relief faster than injectable alternatives and could capture a significant share of the HAE market, which is expected to reach $3.8 billion by 2031. KalVista has also licensed commercialization rights in Canada and Japan.