Kalvista Pharmaceuticals Inc KALV shares are trading lower by 52.42% to $6.78 Tuesday morning after the company announced it terminated the KOMPLETE phase 2 clinical trial for KVD824 for the prevention of attacks in people with hereditary angioedema.
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Kalvista Pharmaceuticals says this decision was based on the observation of liver enzyme (ALT/AST) elevations in multiple patients in all treatment groups of the trial. No patients had concomitant elevation of bilirubin levels and all were asymptomatic.
"The health and safety of participants in our clinical trials is of utmost importance to us," said Andrew Crockett, Chief Executive Officer of KalVista. "We made the difficult decision to terminate KOMPLETE because we concluded that the emerging safety profile of the current formulation will not meet our requirements for a best-in-class oral prophylactic therapy."
"This termination conserves our financial resources and allows us to focus on continuing to advance sebetralstat through the ongoing phase 3 program and towards a planned 2024 NDA filing, as well as on our emerging oral Factor XIIa inhibitor program as a potential once daily prophylactic therapy for people with HAE," Crockett stated.
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According to data from Benzinga Pro, Kalvista Pharmaceuticals has a 52-week high of $18.53 and a 52-week low of $6.70.
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