KalVista Pharmaceuticals secured FDA approval for Ekterly, an oral treatment for hereditary angioedema (HAE) attacks in patients aged 12 and above. The drug, sebetralstat, offers a convenient alternative to injectable treatments and demonstrated symptom relief in pivotal Phase 3 trials. Despite an FDA review delay caused by resource constraints, the approval followed robust clinical data and positions KalVista to compete in a niche market projected to peak at $3.8 billion by 2031. The move marks a key milestone for the company and introduces the first oral on-demand therapy for HAE in the U.S.