KalVista’s path to FDA approval for Ekterly included unexpected review delays attributed to agency resource limitations. The company described regulatory discussions with FDA reviewers as thorough and constructive, culminating in approval. Ekterly presents a competitive edge in hereditary angioedema treatment with rapid symptom relief and oral administration, differentiating from existing injectables. The delay impacted stock price but the approval has revitalized investor confidence, reflecting strong market anticipation for the drug.