US FDA approves KalVista Pharma's swelling disorder drug
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary swelling disorder, sending its shares up 33.3% in premarket trading.
KalVista: Poised For Rare Disease Transformation
KalVista's lead asset, sebetralstat, is nearing FDA approval, targeting hereditary angioedema with a first-in-class oral treatment, presenting a significant market opportunity. Strong financial position with $253.2 million in cash, bolstered by $160 million in recent financing, ensures readiness for commercialization. Strategic partnerships, including a licensing deal with Kaken Pharmaceutical in Japan, and successful pediatric trial progress, de-risk and expand market potential.
Bullish On KalVista Pharmaceuticals: Sebetralstat Nears Approval, Aiming For 2025 Launch
KalVista Pharmaceuticals develops oral small-molecule therapies for hereditary angioedema targeting plasma kallikrein and Factor XIIa. Sebetralstat completed Phase 3 trials and submitted an NDA in June 2024. The company targets 2025 US, EU, UK, and Japan launches. KalVista raised $150.1 million in February 2024, securing a cash runway approximately 2.2 years after the raise.
