FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

The FDA has delayed its decision on KalVista Pharmaceuticals' oral hereditary angioedema (HAE) drug, sebetralstat, past the original Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025, citing a heavy workload and limited resources as the cause of the delay123.

The FDA notified KalVista on June 13, 2025, and expects to deliver a decision within approximately four weeks from the original PDUFA date134.

The agency has not requested any additional data or studies and has not raised concerns about the safety, efficacy, or approvability of sebetralstat; the only remaining review item is believed to be the finalization of labeling123.

KalVista's CEO, Ben Palleiko, expressed disappointment over the delay but remains confident in near-term approval and reiterated the company's commitment to bringing this new oral on-demand option to HAE patients13.

The delay briefly impacted KalVista's stock, which declined 12% over the week but remains up 45% over the last six months2.

Sources:

1. https://www.contemporarypediatrics.com/view/fda-will-not-meet-original-pdufa-data-for-sebetralstat-to-treat-hae

2. https://www.investing.com/news/analyst-ratings/fda-delays-kalvistas-sebetralstat-decision-due-to-resource-constraints-93CH-4097149

3. https://www.businesswire.com/news/home/20250613608281/en/KalVista-Pharmaceuticals-Announces-FDA-Will-Not-Meet-PDUFA-Goal-Date-for-Sebetralstat-NDA-for-Hereditary-Angioedema-Due-to-FDA-Resource-Constraints

4. https://ir.kalvista.com/news-releases/news-release-details/kalvista-pharmaceuticals-announces-fda-will-not-meet-pdufa-goal