Pharvaris N.V. (NASDAQ:PHVS) jumped 20% on Wednesday after the biotech announced highly positive topline findings from its Phase 3 RAPIDe-3 trial evaluating deucrictibant, its oral therapy designed to treat hereditary angioedema (HAE) attacks.
The pivotal study achieved its primary goal, showing that patients receiving deucrictibant reached a median onset of symptom relief in just 1.28 hours, compared with more than 12 hours in the placebo group. The company also reported that all 11 secondary endpoints were statistically significant, with the drug delivering faster symptom improvement and earlier complete resolution versus placebo.
Key data points showed a median time to End of Progression of 17.47 minutes for deucrictibant, compared with 228.67 minutes for placebo. Median time to full symptom resolution was 11.95 hours for those treated with the oral therapy, versus more than 24 hours for placebo. The treatment demonstrated consistent efficacy across HAE subtypes as well as across different attack severities and locations.
A total of 134 patients from 24 countries took part in the trial, including both adolescents and adults with various forms of HAE. Among all recorded attacks, 83% were managed with only a single capsule of deucrictibant, and 93.2% did not require any rescue medication.
Marc A. Riedl, principal investigator for RAPIDe-3, commented, “Bradykinin B2 receptor antagonism is a proven and effective mechanism for treatment of bradykinin-mediated angioedema. Injectable and oral on-demand therapies for HAE are available, however unmet medical needs remain. Effective, well-tolerated, and convenient acute treatment is an essential part of all HAE management plans due to unpredictable angioedema symptoms. The comprehensive and compelling outcomes of RAPIDe-3, specifically the fast treatment response and early complete symptom resolution, demonstrate the potential benefits of deucrictibant as an important on-demand treatment for people living with HAE.”
Pharvaris said it plans to begin submitting marketing applications in the first half of 2026, including a New Drug Application to the U.S. FDA within the same window.