FDA Approves KalVista’s EKTERLY (sebetralstat) for Hereditary Angioedema; Shares Rise 19% on Immediate Launch

KalVista Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema (HAE), a rare and potentially life-threatening condition characterized by severe swelling attacks. The approval follows a delay and a brief intervention attempt by Makary. KalVista immediately launched the drug upon approval, which led to a rise in the company's shares by over 17% in premarket trading and up to 19% during early trading. EKTERLY represents a significant advancement in HAE treatment by providing patients with an oral alternative to manage acute swelling attacks. The approval has been noted alongside other developments in the dermatology and rare disease treatment sectors.