Five months after getting slapped with a clinical hold, KalVista gets the OK to restart oral HAE program
KalVista’s oral program for the prevention of hereditary angioedema (HAE) was only on hold for five months — but that was enough time for rival Pharvaris to close in with its own on-demand and prophylactic treatment. Now that KalVista has the FDA’s permission to continue dosing patients, it’s sprinting to take the lead in Phase II.
The FDA lifted a clinical hold on KalVista’s KVD824 program after reviewing the company’s responses to a request for more information and analysis related to certain preclinical trials, the company announced early Tuesday morning. The news sent the trans-Atlantic biotech’s stock $KALV up 6.25% in premarket trading.
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