FDA Accepts Pharvaris Deucrictibant NDA
Analysis based on 8 articles · First reported Jul 06, 2026 · Last updated Jul 06, 2026
The acceptance of Pharvaris' NDA by the United States — Food and Drug Administration is a significant positive for the company, potentially leading to the launch of a new oral treatment for Hereditary Angioedema. This development could boost investor confidence in Pharvaris and the broader biopharmaceutical sector focused on rare diseases, as it signals progress in bringing innovative therapies to market.
The United States — Food and Drug Administration has accepted Pharvaris' New Drug Application (NDA) for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks. This marks a major milestone for Pharvaris after 10 years of dedicated effort, with a Prescription Drug User Fee Act (PDUFA) target action date set for April 23, 2027. Deucrictibant IR, if approved, would be the first oral bradykinin B2 receptor antagonist for HAE attacks. The NDA includes positive data from the RAPIDe-3 Phase 3 study, which met all primary and secondary efficacy endpoints, demonstrating rapid and sustained relief of HAE attack symptoms and a well-tolerated safety profile. Deucrictibant has also received orphan drug designation from the United States — Food and Drug Administration, the International — European Commission, and Switzerland — Swissmedic.
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