KalVista Submits New Drug Application For FDA Review Of Sebetralstat
Portfolio Pulse from Benzinga Newsdesk
KalVista Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for Sebetralstat, an oral plasma kallikrein inhibitor for treating hereditary angioedema (HAE) attacks. The FDA will review the NDA within 60 days, with a decision expected in September. KalVista plans to seek additional marketing authorizations globally in 2024.
June 18, 2024 | 10:32 am
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KalVista Pharmaceuticals has submitted an NDA for Sebetralstat to the FDA, with a decision expected in September. This could significantly impact the company's stock price depending on the FDA's decision.
The submission of an NDA to the FDA is a critical step for any pharmaceutical company. If the FDA accepts the NDA and eventually approves Sebetralstat, it could lead to significant revenue growth for KalVista. The anticipation of the FDA's decision in September is likely to create positive sentiment around the stock in the short term.
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