Pharvaris has adjusted its guidance for topline results from its pivotal Phase 3 RAPIDe-3 trial evaluating deucrictibant for hereditary angioedema (HAE), now expected in Q4 2025.

Pending positive data, the company aims to file for FDA approval in the first half of 2026.

Pharvaris, a late-stage biopharma company developing oral bradykinin B2 receptor antagonists, is advancing its RAPIDe-3 study of deucrictibant, an immediate-release capsule for on-demand treatment of HAE attacks.

While target enrollment has been achieved, the company announced that data collection is still ongoing, shifting the anticipated topline data release to Q4 2025.

“Our phase 3 data may provide evidence of deucrictibant IR’s potential to address the desire of people living with HAE for an on-demand therapy that combines efficacy—from rapid end of progression to fast and complete resolution—and a favorable safety profile, with the convenience of a single-capsule oral dose,” said Berndt Modig, CEO of Pharvaris.

The NDA submission to the US FDA is now planned for the first half of 2026, contingent on positive results from RAPIDe-3.

Pharvaris’ chief medical officer, Dr Peng Lu, said the study had broad scope.

“Importantly, this study is assessing the effects of deucrictibant for people with high unmet need beyond adults with HAE type 1 and 2, such as participants with HAE with normal C1 inhibitor and adolescents between 12 and 17 years, and will be evaluating the effects of deucrictibant in treating laryngeal attacks,” he said.

RAPIDe-3 is evaluating a 20 mg oral dose of deucrictibant in approximately 120 participants aged 12 and older. The study includes individuals with both classic C1 inhibitor deficiency and normal C1INH. The primary endpoint is time to onset of symptom relief, as measured by the Patient Global Impression of Change (PGI-C). Secondary endpoints include time to end of symptom progression, substantial and complete symptom relief, and safety profile measures.