Core Insights - Pharvaris announced pivotal data from the RAPIDe-3 study, confirming the efficacy of deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks, with plans for marketing authorization applications in the first half of 2026 [1][7] Study Design and Results - The RAPIDe-3 study was a global Phase 3, placebo-controlled trial involving 134 participants from 24 countries, assessing the immediate-release (IR) capsule of deucrictibant (20 mg) for HAE treatment [2] - The study achieved statistical significance for the primary endpoint and all 11 secondary efficacy endpoints, making it the first on-demand HAE study compliant with the Core Outcome Set recommended in the AURORA consensus [2][3] Efficacy and Safety - Deucrictibant demonstrated a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo (p<0.0001) [3][4] - All secondary efficacy endpoints were met, including a median time to End of Progression™ of 17.47 minutes and complete symptom resolution in 11.95 hours [3][4] - The safety profile of deucrictibant was well-tolerated, with no serious adverse events reported [5][9] Future Plans - Pharvaris is preparing to submit a New Drug Application (NDA) to the FDA in the first half of 2026 for deucrictibant as an on-demand treatment for HAE attacks [7][10] - An ongoing open-label extension study (RAPIDe-2 Part B) will provide additional efficacy and safety data [7] Company Overview - Pharvaris is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated conditions, including HAE [10] - The company aims to provide therapies that combine injectable-like efficacy with the convenience of oral administration [10]

Core Insights - Pharvaris, a late-stage biopharmaceutical company, is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][4] Presentation Details - Pharvaris announced the acceptance of two abstracts for oral presentation and six for poster presentation at the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Scientific Meeting scheduled for November 6-10, 2025, in Orlando, Florida [1][2] - The oral presentations include: - Clinical Validation of a Kinin Biomarker Assay to Characterize Bradykinin-Mediated Angioedema on November 8 at 4:43 p.m. ET [2] - Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema: CHAPTER-1 Open-Label Extension on November 8 at 4:53 p.m. ET [2] - The poster presentations cover various aspects of Deucrictibant's efficacy and safety in treating hereditary angioedema, scheduled for November 7 [2] Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for the prevention and treatment of bradykinin-mediated angioedema attacks [4] - The company is currently evaluating the efficacy and safety of Deucrictibant in pivotal Phase 3 studies for both the prevention and on-demand treatment of HAE attacks [4]

Core Insights - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][8] - The company announced the acceptance of abstracts for presentation at three upcoming congresses, highlighting its ongoing research and development efforts [1] Upcoming Presentations - At the C1-Inhibitor Deficiency and Angioedema Workshop in Budapest, several presentations will focus on the clinical validation of biomarker assays, long-term prophylactic treatment with oral Deucrictibant, and patient experiences related to acquired angioedema [2] - The 2025 Eastern Allergy Conference and the EAACI Congress 2025 will also feature presentations on the long-term safety and efficacy of oral Deucrictibant for both prophylaxis and treatment of hereditary angioedema attacks [4][5] Research Focus - The presentations will cover various aspects of bradykinin-mediated angioedema, including clinical validation of novel biomarker assays, health-related quality of life improvements, and pharmacokinetics studies [2][3] - Pharvaris is currently evaluating the efficacy and safety of Deucrictibant in pivotal Phase 3 studies for both the prevention and on-demand treatment of HAE attacks [8]