Pharvaris N.V. reports developments as a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists for bradykinin-mediated diseases, including hereditary angioedema and acquired angioedema due to C1 inhibitor deficiency. Its lead program, deucrictibant, is being developed in immediate-release capsule and extended-release tablet forms for on-demand and prophylactic treatment settings.
Recurring updates include clinical data from the RAPIDe and CHAPTER study programs, patient-reported outcome research, scientific publications, presentations at allergy and immunology meetings, financial results, strategic priorities, shareholder voting matters and capital-structure disclosures.
Pharvaris (PHVS) announced publication in The Lancet of phase 3 RAPIDe-3 results for oral deucrictibant treatment of hereditary angioedema attacks.
The placebo-controlled crossover study evaluated a 20 mg immediate-release capsule in adolescents and adults with hereditary angioedema (HAE). It met its primary endpoint and all 11 secondary endpoints with high statistical significance. Time to onset of symptom relief was 1.28 hours, and time to complete symptom resolution was 11.95 hours; both were significantly faster than placebo. Most attacks were adequately controlled with one capsule. No safety signals were observed, and results were consistent across participant subgroups.
U.S. and European approval applications remain under review. The FDA target action date is April 23, 2027.
Pharvaris (PHVS) announced publication in Advances in Therapy of a company-funded analysis examining real-world management of hereditary angioedema (HAE).
The retrospective survey ran from January 2023 to January 2024 across the United States, Europe and Japan. It included assessments from 225 physicians covering 1,131 patients and questionnaires from 279 patients. Findings identified gaps between recommended care and practice: some patients left attacks untreated because they perceived insufficient severity relative to treatment burden, lacked therapy or experienced injection pain. Portability, administration route, perceived efficacy and adverse-event concerns influenced treatment satisfaction and decisions to change treatment.
Pharvaris (PHVS) reported positive topline results from the CHAPTER-3 pivotal Phase 3 study of once-daily oral deucrictibant XR for prophylaxis of hereditary angioedema (HAE) attacks.
The global, double-blind, placebo-controlled trial enrolled 85 adolescents and adults with all three HAE types, randomized 2:1 to deucrictibant XR 40 mg or placebo for 24 weeks. Treatment reduced the mean monthly attack rate by 83% versus placebo across all HAE types (p<0.0001), and by 87% in the 80 participants with HAE Type 1 or Type 2. The primary endpoint and all secondary efficacy endpoints were met with statistical significance, with early-onset protection in the first week sustained through 24 weeks. Deucrictibant XR was well tolerated, with no treatment-related serious adverse events and one discontinuation per arm. Pharvaris plans to use CHAPTER-3 as the basis for marketing applications, including a U.S. NDA for prophylaxis in the first half of 2027.
Pharvaris (PHVS) reported extensive translational, nonclinical, and clinical data on its oral bradykinin B2 receptor antagonist deucrictibant at the Bradykinin Symposium 2026 in Berlin.
In silico, proteomic, and non-human primate (NHP) models clarified species-specific receptor binding, validated a humanized rat model, and showed that an NHP bradykinin challenge model predicts human pharmacokinetic/pharmacodynamic relationships and supports dose selection. LC‑MS proteomics identified nearly 7,000 plasma proteins and over 2,600 differentially abundant proteins in bradykinin-mediated angioedema, implicating kallikrein-kinin and immune pathways.
Phase 3 RAPIDe‑3 data showed oral deucrictibant immediate-release (IR) capsules shortened median time to onset of symptom relief, reduced attack severity, and accelerated complete resolution versus placebo across regions, with validated Patient Global Impression of Change (PGI‑C) endpoints and markedly earlier End of Progression (17.5 vs 228.7 minutes). A Phase 2 CHAPTER‑1 open-label extension demonstrated durable prophylactic efficacy, reducing mean attack rate from 2.18 to 0.12 attacks per month, improving health-related quality of life, and showing no serious treatment-related adverse events or discontinuations. Integrated analyses indicated a favorable cardiovascular safety profile, with stable heart rate, blood pressure, and no QT prolongation or serious arrhythmias.
Pharvaris (Nasdaq: PHVS) reported second quarter 2026 results and a business update focused on its oral bradykinin B2 receptor antagonist deucrictibant for hereditary and acquired angioedema. Cash and cash equivalents were €318 million as of June 30, 2026, versus €292 million at year-end 2025, supported by a $132.3 million underwritten share offering that, according to the company, extends its cash runway into 2028. Q2 2026 loss was €47.8 million, with R&D expenses of €35.0 million and G&A expenses of €15.8 million.
Topline data from CHAPTER-3, a pivotal Phase 3 prophylaxis trial of deucrictibant XR in HAE, are expected in 3Q2026, with enrollment in CHAPTER-4 and the AAE-C1INH Phase 3 CREAATE study progressing. The FDA is reviewing the deucrictibant IR NDA (PDUFA April 23, 2027), and the EMA has validated the MAA. Pharvaris also opened a U.S. expanded access program for deucrictibant IR and promoted Peng Lu to President to align research, development, and commercial functions.
Pharvaris (Nasdaq: PHVS) reported publication in Frontiers in Immunology of the first in-depth qualitative study of acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), an ultra-rare, serious disease with no approved therapies for prevention or treatment of bradykinin-mediated angioedema attacks.
The interviews characterized frequent, painful swelling attacks, prolonged misdiagnoses, emergency care, and broad physical, emotional, social, and work-related impact, with participants relying on off-label therapies. The study evaluated established patient-reported outcome tools (PGI-C, PGI-S, PGA) and found them relevant and interpretable in AAE-C1INH, showing a PGI-C rating of “better” as consistently meaningful up to 4 hours post treatment. According to Pharvaris, these findings informed endpoint selection and design of the ongoing Phase 3 CREAATE trial (NCT07266805) of deucrictibant for prophylaxis and on-demand treatment of AAE-C1INH attacks.
Pharvaris (Nasdaq: PHVS) announced the publication of a comprehensive review in Clinical Reviews in Allergy & Immunology summarizing decades of scientific and clinical evidence on bradykinin biology and the bradykinin B2 receptor (B2R). The article outlines the evolution of B2R antagonism from basic kinin research to a clinically validated therapeutic approach for bradykinin-mediated angioedema, including hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH). According to Pharvaris, the review highlights that B2R antagonists directly block the receptor through which bradykinin drives swelling, independent of upstream mechanisms, and notes that long-term unfavorable effects from B2R antagonism have not been observed to date. The publication also discusses potential applicability of B2R-targeted therapies across broader immunological and inflammatory diseases.
Pharvaris (Nasdaq: PHVS) announced FDA acceptance of its New Drug Application for deucrictibant IR 20 mg capsules as an on-demand treatment for hereditary angioedema (HAE) attacks, with a PDUFA action date of April 23, 2027.
The NDA includes data from over 1,300 HAE attacks. In the pivotal Phase 3 RAPIDe-3 trial, deucrictibant IR met the primary and all 11 secondary efficacy endpoints with statistical significance, showing rapid symptom relief and a well-tolerated safety profile. Deucrictibant received FDA orphan drug designation in 2022.
Pharvaris (Nasdaq: PHVS) reported new EAACI 2026 data on oral deucrictibant for hereditary angioedema (HAE). Phase 3 RAPIDe-3 showed median 1.28 hours to symptom relief and 11.95 hours to complete resolution versus over 12 and 48 hours with placebo, and a median 17.47 minutes to End of Progression™ versus 228.67 minutes.
In Phase 2 CHAPTER-1 long-term prophylaxis, attack rates fell by ~92% on average and about half of participants were attack-free. An integrated analysis in ~570 participants showed a favorable cardiovascular safety profile, and a validated kinin biomarker assay may help differentiate bradykinin-mediated angioedema.
Pharvaris (Nasdaq: PHVS) announced its annual general meeting of shareholders will be held on Friday, June 26, 2026, at 16:00 CEST (10:00 a.m. EDT).
Meeting documents, including the notice and agenda, are available in the website’s Investors > Events & Presentations section and on the SEC website.