Pharvaris expects pivotal HAE study data in third quarter 2026

Pharvaris (NASDAQ: PHVS) announced its strategic priorities for 2026, with topline data from its CHAPTER-3 study of deucrictibant for preventing hereditary angioedema attacks expected in the third quarter of 2026.

The company is preparing to file a New Drug Application with the FDA for deucrictibant's on-demand treatment of HAE attacks in the first half of 2026. The filing is based on data from its RAPIDe-3 and RAPIDe-2 studies.

CHAPTER-3 is a Phase 3 study evaluating deucrictibant extended-release tablets for preventing angioedema attacks in adults and adolescents with HAE. The study aims to enroll approximately 81 participants who will receive either deucrictibant 40 mg or placebo once daily for 24 weeks.

The company's RAPIDe-3 study met its primary endpoint, showing a median time to onset of symptom relief of 1.28 hours for deucrictibant compared to placebo. All secondary efficacy endpoints were also achieved with statistical significance.

Pharvaris is conducting the CREAATE study, a Phase 3 trial of deucrictibant for treating acquired angioedema due to C1 inhibitor deficiency. The study includes both prophylactic and on-demand treatment components.

The biopharmaceutical company estimates its cash runway extends into the first half of 2027. Pharvaris was added to the Nasdaq Biotechnology Index in December 2025.

Deucrictibant is an oral bradykinin B2 receptor antagonist being developed in two formulations: an extended-release tablet for prevention and an immediate-release capsule for on-demand treatment of angioedema attacks. The drug has received orphan drug designation from the FDA, European Commission, and Swissmedic.

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