FDA Delays KalVista Drug Review for HAE

The FDA has delayed its decision on KalVista Pharmaceuticals' oral hereditary angioedema treatment, sebetralstat, due to resource constraints, moving the review past the original June 17, 2025 deadline by about four weeks. The agency has not requested additional data or raised safety or efficacy concerns, with final labeling believed to be the only outstanding issue. Sebetralstat could become the first oral, on-demand therapy for hereditary angioedema, potentially offering a more convenient alternative to current injectable treatments. The delay is disappointing for patients but does not signal regulatory or clinical problems. KalVista remains in a strong financial position, though its stock saw a short-term decline after the delay was announced. Analyst sentiment remains positive for the company’s prospects.