After the delay in approval, the new drug was finally approved by the FDA KalVista (KALV.US) surged nearly 20% before the market

The Zhitong Finance App learned that KalVista Pharmaceuticals (KALV.US) announced that its oral medication to treat hereditary angioedema has been approved by the US Food and Drug Administration (FDA). Hereditary angioedema is a rare and potentially fatal condition that causes severe swelling throughout the body. As of press time, the stock was up 18% before the market on Monday EST.

Last month, the FDA informed Kalvista that it would not be able to make a decision before the June approval deadline. The company said at the time that regulators said the decision was delayed due to “heavy workload and limited resources.”

Whether the recent layoffs in government agencies have led to a slowdown in drug approval has always been a matter of high alert in the pharmaceutical industry. FDA Director Marty Macari has publicly stated that the agency is “fully capable” of completing drug reviews on time.

KalVista's medicine, called Ektly, is the first on-demand oral medication for hereditary angioedema. According to Cleveland Clinic data, about 6,000 people in the US suffer from this more common rare disease.