deucrictibant IR (PHVS416) - (RAPIDe-3)

October 8, 2026: Pharvaris (NASDAQ: PHVS) announced publication in The Lancet of Phase 3 RAPIDe-3 results for oral deucrictibant immediate-release (IR) 20 mg for on-demand treatment of hereditary angioedema (HAE) attacks in adolescents and adults. In the global randomized, double-blind, placebo-controlled crossover study, deucrictibant IR met the primary endpoint and all 11 secondary endpoints with high statistical significance, including faster time to symptom relief (1.28 hours) and complete symptom resolution (11.95 hours) versus placebo. The company said deucrictibant IR also achieved significantly faster End of Progression of attack symptoms, with most attacks adequately controlled with a single capsule.

Safety was described as well tolerated, with no safety signals observed. Results were reported as consistent across subgroups including age, geography, HAE type (including HAE with normal C1 inhibitor), long-term prophylaxis use, and attack severity/location, including non-severe laryngeal attacks.

Regulatory catalysts: the NDA for deucrictibant IR is under FDA review for on-demand HAE treatment, with a PDUFA target action date of April 23, 2027; the MAA is under EMA review. Additional program updates: RAPIDe-2 open-label extension is ongoing, and an expanded access program is available in the U.S.