Clinical EfficacySebetralstat showed significantly faster symptom relief and reduced attack severity in clinical trials, positioning it as a promising first oral therapy for hereditary angioedema.
Product LaunchKalVista Pharmaceuticals is well-prepared for a US launch of sebetralstat, demonstrating strong commercial readiness and engagement with prescribers, payors, and the patient community.
Regulatory ApprovalThe delay in FDA's decision is perceived positively as it suggests a likely approval for sebetralstat, with no additional concerns raised on safety, efficacy, or approvability.