KalVista falls as FDA extends swelling disorder drug review

Kalvista Pharmaceuticals

16/06/2025 11:05

** Drug developer KalVista Pharmaceuticals KALV.O decline about 7.4% to $12 premarket

** FDA extends review of KALV's experimental drug, sebetralstat, citing heavy workload and limited resources

** Health Secretary Robert F. Kennedy Jr. directed the FDA to fire 3,500 employees as part of a massive restructuring of U.S. health agencies in March

** TD Cowen says that the delay does not appears to do with the drug's safety or efficacy

** "Although disappointing, we expect little impact on the launch," says brokerage, adding that they expect significant demand from patients who suffer from a type of swelling disorder called hereditary angioedema

** Co says FDA plans to deliver a decision within four weeks

** KALV up 53% YTD

 (Reporting by Bhanvi Satija in Bengaluru)

 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91 9873062788;))