Shares of Pharvaris (PHVS) are up nearly 7%, following the release of positive topline Phase 3 data from the RAPIDe-3 trial of Deucrictibant in hereditary angioedema (HAE).
The pivotal RAPIDe-3 study evaluated Deucrictibant 20 mg immediate-release capsules for the on-demand treatment of HAE in patients 12 years and older.
The trial enrolled 134 patients across 24 countries, making it the most representative global population studied in on-demand HAE treatment to date. The trial met its primary endpoint, with a median time to onset of symptom relief of 1.28 hours compared to more than 12 hours for placebo.
All 11 secondary endpoints were also achieved, including median time to End of Progression at 17.47 minutes versus 228.67 minutes for placebo, and complete symptom resolution at 11.95 hours versus more than 24 hours.
Deucrictibant, designed to inhibit bradykinin signalling through the B2 receptor, demonstrated rapid efficacy and a favourable safety profile. In the study, 83% of attacks were treated with a single capsule, and 93% required no rescue medication. No-treatment-related serious adverse events were reported, and no patients discontinued due to adverse events.
Marc A. Riedl, M.D., principal investigator of RAPIDe-3, noted that the fast treatment response and early complete symptom resolution highlight deucrictibant's potential as a convenient and effective oral therapy for HAE.
Pharvaris plans to submit a New Drug Application for Deucrictibant to the U.S. FDA in the first half of 2026 for the on-demand treatment of acute HAE attacks.
An open-label extension of deucrictibant for the on-demand treatment of HAE attacks, RAPIDe-2 Part B, is ongoing to provide long-term treatment and safety follow-up.
Pharvaris is also advancing deucrictibant in prophylactic settings through the ongoing CHAPTER 3 Phase 3 study, with topline data expected in the second half of 2026. If successful, deucrictibant could become the first oral therapy to offer both on-demand and prophylactic control of bradykinin-mediated angioedema.
PHVS closed yesterday's trading at $24.12, down 1.88%. In premarket trading today, the stock is up nearly 7% at $25.
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