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Pharvaris NDA acceptance for deucrictibant IR could unlock oral HAE therapy

Jul 6, 2026, 6:53 AM EDT1 sourcesAI-analyzed

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Regulatory milestones (NDA acceptance, known PDUFA date) historically drive outsized moves in biotech, especially for first-in-class oral agents with orphan-designated products.

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Pharvaris announced FDA accepted the NDA for deucrictibant immediate-release (IR) 20 mg for on-demand treatment of hereditary angioedema (HAE), with a PDUFA date of April 23, 2027. Phase 3 RAPIDe-3 showed rapid onset (median 1.28 hours) and complete symptom resolution in about 11.95 hours, supporting a potentially differentiated, oral on-demand option if approved.

FDA accepts Pharvaris NDA for deucrictibant IR in HAE on-demand.
PDUFA target date set for April 23, 2027.
RAPIDe-3 phase 3 met primary and all 11 secondary endpoints.
IR formulation could be first oral B2 antagonist if approved.

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Pharvaris NDA acceptance for deucrictibant IR could unlock oral HAE therapy

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