FDA slaps clinical hold on Pharvaris' PHA121 trials

23 August 2022

Pharvaris (Nasdaq: PHVS), a Switzerland-based clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced that the US Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of non-clinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the USA under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE.

The news sent Pharmvaris’ shares tumbling 34% to $12.14 by close of trading yesterday.

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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