DRI Healthcare Trust Comments on FDA Delay for KalVista Pharmaceuticals' Sebetralstat PDUFA Goal Date Due to FDA Resourcing Constraints
- FDA decision anticipated within four weeks -
TORONTO, June 13, 2025 /CNW/ - DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) (the "Trust") today announced KalVista Pharmaceuticals ("KalVista") has disclosed that it has received notice from the U.S. Food and Drug Administration ("FDA") that the FDA will not meet the June 17, 2025 PDUFA goal date for the New Drug Application (NDA) for sebetralstat, due to a heavy workload and agency resourcing issues. KalVista commented that the FDA has not requested additional data or studies and has communicated to KalVista that it anticipates delivering a decision within approximately four weeks.
KalVista issued its own press release with the announcement earlier today (link).
About DRI Healthcare Trust
The Trust is managed by DRI Capital Inc., a pioneer in global pharmaceutical royalty monetization. Since its initial public offering in 2021, the Trust has deployed more than $1.0 billion, acquiring more than 25 royalties on 20-plus drugs, including Eylea, Orserdu, Omidria, Spinraza, Stelara, Vonjo, Zejula and Zytiga. The Trust's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol "DHT.UN" and in U.S. dollars under the symbol "DHT.U". To learn more, visit drihealthcare.com or follow us on LinkedIn.
SOURCE DRI Healthcare Trust
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