- The FDA verbally placed a clinical hold on Pharvaris NV's PHVS PHA121 in the U.S. under two Pharvaris Investigational New Drug (IND) applications for Hereditary angioedema (HAE).
- HAE is a disease characterized by painful swelling under the skin and lining of the gut and lungs.
- The move follows the FDA's review of nonclinical data.
- The FDA indicated it would provide a formal clinical hold letter to Pharvaris in approximately 30 days.
- The company plans to provide additional updates following interactions with the FDA.
- HAE is caused by a deficiency in the blood plasma protein C1 esterase inhibitor, and both Haegarda and Cinryze try to boost the protein level in the blood. Firazyr blocks bradykinin, a blood protein overproduced in HAE. Elevated bradykinin levels cause blood cells to leak and tissues to swell.
- Pharvaris' drug PHA121 is a bradykinin B2 receptor antagonist.
- Price Action: PHVS shares are down 35% at $11.95 on the last check Monday.
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