Pharvaris: FDA Has Placed U.S. Angioedema Trials on Clinical Hold
August 22 2022 - 7:36AM
Dow Jones News
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 Will.Feuer@wsj.com
(END) Dow Jones Newswires
August 22, 2022 07:21 ET (11:21 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Pharvaris NV (NASDAQ:PHVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pharvaris NV (NASDAQ:PHVS)
Historical Stock Chart
From Apr 2023 to Apr 2024
