FDA Delays KalVista Sebetralstat Review Citing Resource Constraints

KalVista Pharmaceuticals recently received notice from the FDA that the review deadline for its hereditary angioedema treatment, sebetralstat, will be delayed due to agency resourcing constraints, pushing the decision approximately four weeks beyond the original June 17, 2025 goal date. The FDA has not requested additional data or raised safety concerns, and KalVista has fulfilled all prior information requests, with final label approval expected to be the remaining step. Despite the delay, Wall Street analysts remain optimistic, with an average one-year price target of $27.25, suggesting a significant potential upside from the current stock price. The consensus brokerage rating classifies KalVista as an 'Outperform,' reflecting positive investor sentiment. DRI Healthcare Trust, which has royalty interests including KalVista's drug, noted the FDA delay but maintains a neutral stance on its own stock, highlighting profitability challenges but a positive outlook due to improved financial results and strategic management. The delay may impact KalVista’s market positioning and stakeholder expectations, but investor confidence remains strong overall.