11:57 AM EDT, 09/03/2024 (MT Newswires) -- KalVista Pharmaceuticals ( KALV ) said Tuesday the US Food and Drug Administration has accepted its New Drug Application (NDA) for sebetralstat to treat hereditary angioedema attacks, with a target action date of June 17, 2025.
KalVista said the FDA is not currently planning to hold an advisory committee meeting on the application.
The company said it is seeking approval for sebetralstat, an investigational oral plasma kallikrein inhibitor, in patients aged 12 and older.
The application was supported by data from a phase 3 clinical trial and an ongoing open label extension trial, the company said.
Shares of KalVista were down 5.9% in recent trading.
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