04:34 PM EDT, 06/13/2025 (MT Newswires) -- KalVista Pharmaceuticals ( KALV ) said Friday that the US Food and Drug Administration will not be able to meet the PDUFA goal date of June 17 for the new drug application for the company's investigational drug sebetralstat due to heavy workload and limited resources.

The FDA indicated that it expects to deliver a decision within approximately four weeks, KalVista said.

The company said the agency has not asked for additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat, which is an oral plasma kallikrein inhibitor for the treatment of hereditary angioedema, a rare genetic disease.