Core Viewpoint - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, targeting unmet needs in bradykinin-mediated diseases, with topline data from the RAPIDe-3 Phase 3 study expected in Q4 2025 and a potential NDA submission in H1 2026 [1][2][4] Group 1: Study and Data - The RAPIDe-3 study has achieved target enrollment, and the topline data announcement is now anticipated in the fourth quarter of 2025 [2] - The study evaluates deucrictibant immediate-release capsules (20 mg) for on-demand treatment of angioedema attacks in approximately 120 participants aged 12 and older, including those with C1 inhibitor deficiency [2][3] - Primary endpoints include time to onset of symptom relief and other measures of symptom resolution and safety [2][3] Group 2: Drug Development - Deucrictibant is being developed in two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for rapid treatment [3][4] - The drug has received orphan drug designation from the FDA and the European Commission for treating bradykinin-mediated angioedema [3] Group 3: Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for bradykinin-mediated angioedema [4] - The company is conducting multiple pivotal Phase 3 studies, including CHAPTER-3 for prevention and RAPIDe-3 for on-demand treatment of HAE attacks [4]

Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026Attack dataset continues to accumulate in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, strengthening confidence in clinical timelinesTQT study waivers received from FDA for both deucrictibant extended-release formulation and deucrictibant immediate-release formulationPharvaris Management to host R&D call on June 4 at 8:00 ...