Pharvaris: FDA Has Placed U.S. Angioedema Trials on Clinical Hold

By Will Feuer

Clinical-stage research company Pharvaris NV said the U.S. Food and Drug Administration has placed a clinical hold on the U.S. trials of its treatment of hereditary angioedema attacks.

The FDA verbally informed Pharvaris that, based on its review of nonclinical data, the agency is placing a clinical hold on the trials of its PHA121 drug in the U.S. under two investigational new drug applications for the treatment of HAE.

HAE is a disease characterized by recurrent episodes of severe swelling of the skin and mucous membranes, according to the National Institutes of Health. In the U.S., fewer than 50,000 people are estimated to be affected by the disease, according to the NIH.

The FDA indicated it will provide a formal clinical hold letter to Pharvaris in about 30 days. The company plans to provide additional updates following interactions with the FDA.

"We are fully committed to working closely with the FDA to address the agency's concerns," Pharvaris Chief Executive Berndt Modig said. "Pharvaris remains dedicated to providing new therapeutic choices for the treatment of HAE and is working diligently to bring PHA121 to people living with HAE."

Shares of Pharvaris slid almost 19%, to $15 a share, in premarket trading.

Write to Will Feuer at [e-mail]

(END) Dow Jones Newswires

August 22, 2022 07:21 ET (11:21 GMT)

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