Pharvaris said on Thursday that phase 3 results for deucrictibant immediate-release capsules in hereditary angioedema, or HAE, have been published in The Lancet. The company said the RAPIDe-3 study found faster symptom relief and complete symptom resolution, while U.S. and European regulators are already reviewing the treatment for on-demand use in HAE attacks.
For retail traders, the main point is not a trading signal but a clinical milestone for a late-stage biotech. Pharvaris said RAPIDe-3 was a global, randomized, double-blind, placebo-controlled crossover study in adolescents and adults, and that the drug met its primary endpoint and all 11 secondary endpoints with high statistical significance.
The company said treatment with deucrictibant IR led to a time to onset of symptom relief of 1.28 hours and a time to complete symptom resolution of 11.95 hours. It also said most attacks were adequately controlled with a single capsule, that the drug was well tolerated, and that no safety signals were observed.
Pharvaris added that the results were consistent across subgroups defined by age, geographic location, HAE type, use of long-term prophylaxis, and attack severity and location, including non-severe laryngeal attacks. Marc A. Riedl, principal investigator and lead author of the publication, said the results demonstrated that deucrictibant IR rapidly ended attack progression and accelerated the time to complete symptom resolution.
The company said a New Drug Application, or NDA, is under review with the U.S. Food and Drug Administration and has a Prescription Drug User Fee Act target action date of 23 April 2027. A Marketing Authorization Application, or MAA, is also under review with the European Medicines Agency.
Pharvaris also said results from RAPIDe-3 were consistent with RAPIDe-1, published in April 2026 in The Lancet Haematology, and that an open-label extension study, RAPIDe-2, is ongoing. An expanded access program is also available to eligible people in the U.S.
ประเด็นสำคัญ
- The RAPIDe-3 phase 3 study was published in The Lancet.
- Time to symptom relief was 1.28 hours and complete symptom resolution was 11.95 hours.
- The drug showed a well-tolerated safety profile and no safety signals were observed.
- NDA and MAA reviews are under way with the FDA and EMA.



