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DRI Healthcare Notes FDA Delay for KalVista's' Sebetralstat New Drug Approval on "Resourcing" Issues
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DRI Healthcare Notes FDA Delay for KalVista's' Sebetralstat New Drug Approval on "Resourcing" Issues
Jun 16, 2025 4:36 AM

07:12 AM EDT, 06/16/2025 (MT Newswires) -- DRI Healthcare Trust (DHT-UN.TO, DHT-U.TO) over the weekend said it has been notified by KalVista Pharmaceuticals that the U.S. Food and Drug Administration will miss the June 17 goal date to decide on the new drug application for sebetralstat, due to a heavy workload and "resourcing" issues.

The FDA has not requested additional data or studies and expects to render a decision on whether to approve the new medication in four weeks, a statement noted. Sebetralstat is an investigational oral treatment for hereditary angioedema (HAE).

DRI acquired a royalty interest in the worldwide net sales of sebetralstat in November 2024 for an US$100 million upfront payment, and up to US$57 million in a sales-based milestone payment and a one-time US$22 million optional payment. The Trust also made a US$5 million investment in KalVista in a private placement transaction.

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