RAPIDe-3 results strengthen Pharvaris' case for first oral HAE therapy
Oct 8, 2026, 6:42 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting
Positive Phase 3 results and publication plus regulatory submissions create near-term upside risk/reward; potential first-mover oral HAE therapy could drive multiple expansion if approvals occur, though delay/regulatory risk could cap upside.
AI summary
What happened, with direct paths to the underlying reporting
Pharvaris reports RAPIDe-3 shows deucrictibant IR delivers rapid HAE attack relief, with 1.28-hour onset and 11.95-hour resolution. The Lancet publication plus pending FDA and EMA reviews create near-term catalysts, with a 2027 PDUFA target. If approved, it would be the first oral bradykinin B2 receptor antagonist for on-demand HAE, potentially shifting treatment standards.
All endpoints met with high statistical significance across 11 secondary endpoints.
Lancet publication boosts global visibility for deucrictibant IR.
FDA NDA and EMA MAA under review; PDUFA date 2027-04-23.
RAPIDe-2 open-label extension and EAP ongoing; orphan designation granted.
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