FDA to Delay Decision on KalVista’s New Drug Application Due to Workload

TL/DR –

KalVista Pharmaceuticals has been informed by the US Food and Drug Administration (FDA) that it will not meet the June 17, 2025, PDUFA goal date for the New Drug Application (NDA) for sebetralstat due to workload and resourcing issues. The FDA has not requested additional data or studies from KalVista and expects to deliver a decision within approximately four weeks. DRI Healthcare Trust, which announced the news, has deployed more than $1.0 billion, acquiring more than 25 royalties on over 20 drugs since its initial public offering in 2021.

FDA decision expected within four weeks

TORONTO, June 13, 2025 – DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) announced that KalVista Pharmaceuticals has been informed by the FDA that the PDUFA goal date for sebetralstat’s New Drug Application (NDA) will not be met due to agency heavy workload and resourcing issues. The FDA has not requested additional data and estimates a decision within four weeks.

KalVista published a press release with the announcement earlier today (link).

About DRI Healthcare Trust

DRI Healthcare Trust is managed by DRI Capital Inc., a pioneer in pharmaceutical royalty monetization. Since its 2021 initial public offering, the Trust has deployed over $1.0 billion, acquiring royalties on over 20 drugs, including Eylea and Zytiga. The Trust’s units trade on the Toronto Stock Exchange under “DHT.UN” and “DHT.U”. Visit drihealthcare.com or follow on LinkedIn.

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