2024-01-22 07:09:06 ET
Shares of Swiss biotech Pharvaris ( NASDAQ: PHVS ) gained 6.27% premarket on Monday after U.S. regulators lifted a clinical hold on testing for its proposed treatment for hereditary angioedema, or HAE.
Pharvaris ( PHVS ) said the U.S. Food and Drug Administration (FDA) has lifted a hold on its investigational new drug application for its drug deucrictibant for the prophylactic treatment of HAE attacks following review of data from a 26-week rodent toxicology study.
The lifting follows positive top-line data from the Phase 2 CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks. Previously, in June 2023, the health regulator had lifted clinical hold on deucrictibant for the on-demand treatment of HAE in the U.S.
"The lift of the clinical hold in the U.S. enables us to progress the global development of deucrictibant for long-term prophylaxis, including resuming the open-label portion of CHAPTER-1, our Phase 2 proof-of-concept study of deucrictibant for the prevention of HAE attacks, in the U.S.," said CEO Berndt Modig.
The company plans to request an End-of-Phase 2 meeting with the FDA to align on key elements of its anticipated global Phase 3 study of deucrictibant extended-release tablets for the prophylactic treatment of HAE attacks.
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Pharvaris rises as FDA lifts hold on hereditary angioedema candidate