KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) saw its stock soar by 19% after receiving FDA approval for EKTERLY (sebetralstat)—the first oral, on-demand treatment for hereditary angioedema (HAE), a rare and potentially life-threatening genetic condition.
The green light from regulators represents a major breakthrough for HAE patients, who until now had no alternative to injectable therapies for managing sudden swelling attacks. EKTERLY is now authorized for use in patients 12 years and older, offering a convenient oral tablet to treat attacks as soon as symptoms appear.
“This approval is a major advance in empowering patients with more control and independence over their treatment,” said Dr. Marc A. Riedl, a professor at the University of California, San Diego, and an investigator in the KONFIDENT Phase 3 trial that supported the drug’s approval.
Data from that pivotal trial—the largest ever conducted for HAE—demonstrated that EKTERLY provided faster symptom relief, shortened attack duration, and reduced severity compared to placebo. The study enrolled 136 patients across 66 sites in 20 countries, highlighting the global scope of KalVista’s clinical program.
KalVista announced that EKTERLY will be available immediately in the U.S., with prescriptions now open to physicians. The company also launched KalVista Cares, a support program offering assistance with insurance coverage, access coordination, and patient education.
HAE, while rare, is a chronic genetic disorder marked by sudden swelling episodes that can affect the skin, gastrointestinal tract, or airways. Many patients still experience breakthrough attacks even while on preventative medication, making fast-acting, on-demand treatments like EKTERLY critical for disease management.