Pharvaris, a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, announced that the US Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of nonclinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the US under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE. The FDA indicated it will provide a formal clinical hold letter to Pharvaris in approximately 30 days. The company plans to provide additional updates following interactions with the FDA.
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