Pharvaris HAE pill data published in The Lancet ahead of FDA review

Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due

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A naturally lit room features a light-colored recliner chair beside an IV stand with a clear bag and coiled tube, and a small side table holding a potted plant and a glass, all against a backdrop of soft curtains.

Pharvaris has published full Phase 3 results for its oral hereditary angioedema treatment deucrictibant immediate-release (IR) in The Lancet, with the RAPIDe-3 trial meeting its primary endpoint and all 11 secondary endpoints at high statistical significance. The Swiss-registered, Nasdaq-listed company said the data reinforce the case for regulatory approval in both the United States and Europe, where a New Drug Application (NDA) and a Marketing Authorisation Application (MAA) are already under active review.

RAPIDe-3 was a global, randomised, double-blind, placebo-controlled crossover study enrolling adolescents and adults. Patients treated with deucrictibant IR achieved onset of symptom relief in a median 1.28 hours and complete symptom resolution in a median 11.95 hours. The company said most attacks were adequately controlled with a single 20 mg capsule, and that the drug showed a well-tolerated safety profile with no notable safety signals. Results were consistent across subgroups defined by age, geography, HAE type, use of long-term prophylaxis, and attack location, including non-severe laryngeal attacks.

Clinical significance

Marc Riedl, Professor of Medicine and Clinical Director of the Hereditary Angioedema Association Angioedema Centre at the University of California San Diego and the study's principal investigator, said deucrictibant IR "rapidly ended attack progression and accelerated the time to complete symptom resolution." He described publication in The Lancet, which carries a journal impact factor of 109, as maximising visibility of the data to a global network of clinicians and researchers.

Peng Lu, President of Pharvaris, emphasised that the consistent cross-subgroup findings reflect the downstream nature of bradykinin B2 receptor antagonism as a target, noting the mechanism interrupts excess bradykinin signalling regardless of the upstream pathway through which it is generated. The company is also developing an extended-release tablet formulation of deucrictibant for prophylactic use, and an open-label extension study, RAPIDe-2, remains ongoing.

Regulatory and competitive context

The FDA has set a PDUFA target action date of 23 April 2027 for the deucrictibant NDA. If approved, Pharvaris says deucrictibant IR would be the first oral bradykinin B2 receptor antagonist to reach the market, positioning it as a convenient alternative in a space currently served mainly by injectable and intravenous therapies. The EMA review of the MAA is running in parallel.

HAE is a rare, potentially life-threatening condition driven by episodic attacks of swelling, typically caused by insufficient or dysfunctional C1 inhibitor protein. The existing on-demand treatment landscape includes injectable icatibant, a subcutaneous bradykinin B2 receptor antagonist, as well as intravenous C1 inhibitor concentrates and plasma kallikrein inhibitors. An oral agent that matches the efficacy profile of injectables would represent a meaningful shift in patient experience for a condition requiring acute, often self-administered treatment. The RAPIDe-3 results, supported by consistent earlier data from RAPIDe-1 published in The Lancet Haematology in April 2026, strengthen Pharvaris's regulatory package at both agencies. Investors and clinicians will be watching closely for the FDA's response ahead of the April 2027 PDUFA date, and for longer-term durability data from the open-label extension.

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