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High materiality8/10

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.

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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.

  • RAPIDe-3: onset 1.28h; complete resolution 11.95h.
  • 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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