Pharvaris shares Phase 3 HAE data as Lancet study lands

Pharvaris said results from its Phase 3 RAPIDe-3 study of deucrictibant immediate-release, or IR, have been published in The Lancet, with the treatment showing faster symptom relief and complete symptom resolution in attacks of hereditary angioedema, or HAE. The company said the study involved adolescents and adults and used a 20 mg oral capsule in a global, randomized, double-blind, placebo-controlled crossover design.

In the study, deucrictibant IR reached symptom relief in 1.28 hours and complete symptom resolution in 11.95 hours, according to the company. Pharvaris also said the treatment was well tolerated, with no safety signals observed.

The company said RAPIDe-3 met its primary endpoint and all 11 secondary endpoints with high statistical significance. It added that most attacks were adequately controlled with a single capsule, and that results were consistent across subgroups defined by age, geography, HAE type, use of long-term prophylaxis, and attack severity and location, including non-severe laryngeal attacks.

The filing picture is also part of the story for anyone following the name in a retail account. Pharvaris said a New Drug Application, or NDA, for deucrictibant IR is under review by the U.S. Food and Drug Administration, or FDA, with a Prescription Drug User Fee Act target action date of 23 April 2027. It also said a Marketing Authorization Application, or MAA, is under review by the European Medicines Agency, or EMA.

Pharvaris said an open-label extension study, RAPIDe-2, is ongoing, and that an expanded access program is also available to people in the U.S. who meet eligibility requirements. The company added that results from RAPIDe-3 were consistent with RAPIDe-1, published in April 2026 in The Lancet Haematology.