- Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026
- Deucrictibant IR NDA under review by the FDA with PDUFA date of April 23, 2027; MAA validated by the EMA in July 2026
- Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks
- Strong financial position with cash and cash equivalents of €318 million as of June 30, 2026
ZUG, Switzerland, Aug. 12, 2026 (GLOBE NEWSWIRE) — Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated angioedema (AE-BK), such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the second quarter ending on June 30, 2026, and provided a business update.
“Pharvaris continues to make strong progress advancing deucrictibant IR toward potential regulatory approval, moving closer to our goal of helping address unmet needs of people living with HAE by providing a therapy that can offer rapid and sustained attack relief and resolution with a single oral capsule. In parallel to our recent regulatory successes, our ongoing pre-commercial activities are designed to support a timely, successful U.S. launch,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Announcing pivotal data from CHAPTER-3, expected this quarter, will mark another key milestone for Pharvaris as we develop deucrictibant for both the prevention and on-demand treatment of bradykinin-mediated angioedema attacks. The financing we completed in May extends our cash runway into 2028, enabling us to properly prepare for deucrictibant’s launch and consider lifecycle management opportunities while maintaining capital discipline.”
Recent Business Updates
Development Pipeline
- Topline data from CHAPTER-3 (NCT06669754) expected in 3Q2026. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. Eighty-five participants were enrolled and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg/day), the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris expects to announce topline data from CHAPTER-3 in the third quarter of 2026.
- Enrollment in CHAPTER-4 (NCT06679881) progressing as planned. CHAPTER-4 is a long-term, open-label extension study of orally administered deucrictibant XR (40 mg/day) for the prophylactic treatment of HAE attacks. The goal of the study is to evaluate the long-term safety and effectiveness of deucrictibant XR in the prophylactic treatment of HAE attacks.
- Review of marketing authorization applications of deucrictibant immediate-release (IR) capsule as a potential on-demand treatment of HAE attacks underway by regulatory authorities. In July 2026, the U.S. Food and Drug Administration (FDA) accepted to review the Company’s New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks, with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027. In July 2026, the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for deucrictibant IR and began its formal review of the MAA under the centralized procedure.
- Expanded Access Program (EAP) for deucrictibant IR for the on-demand treatment of HAE attacks opened in the U.S. EAPs are a potential pathway for people with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The U.S. EAP for deucrictibant IR is available to people in U.S. living with HAE meeting eligibility requirements. Healthcare professionals interested in making requests for access to deucrictibant IR through the EAP can refer to https://mytomorrows.com/pharvaris/healthcareprofessional/ and/or email Pharvaris’ Medical Affairs at expandedaccess@pharvaris.com.
- Enrollment in CREAATE (NCT07266805) progressing as planned. CREAATE is a global, pivotal Phase 3 study evaluating orally administered deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks.
- Assessment of AAE-C1INH disease burden and validation of clinical trial endpoints published in Frontiers in Immunology. Qualitative interviews provided evidence of the impact of AAE-C1INH on participants’ lives and overall well-being, and the study findings informed the clinical outcome assessment strategy for CREAATE, the first phase 3 clinical trial specifically studying AAE-C1INH.
- Evidence supporting bradykinin B2 receptor as a validated therapeutic target in bradykinin-mediated angioedema published in Clinical Reviews in Allergy & Immunology. This summary of the growing body of evidence explores the critical role of bradykinin B2 receptor in the pathogenesis of bradykinin-mediated angioedema and supports bradykinin B2 receptor antagonism as a therapeutic strategy for bradykinin-mediated diseases, including HAE and AAE-C1INH, as well as, potentially, other allergic and immunological conditions.
Corporate
- Peng Lu, M.D., Ph.D., promoted to newly created role of President. Leveraging the company’s scientific rigor and reflecting the depth of Dr. Lu’s contributions, Pharvaris has brought its research, development, and commercial functions under one leadership structure by promoting Dr. Lu to President, effective June 2026, strengthening Pharvaris’ ability to deliver on its strategic priorities.
- Closed $132 million underwritten offering. The proceeds from the offering of $132.3 million of shares extends cash runway into 2028.
Upcoming Investor Events
- Wells Fargo 21st Annual Healthcare Conference. Boston, MA, Sept. 8-10, 2026.
- Format: Fireside Chat
Date, time: Wednesday, Sept. 9, 4:30 p.m. EDT
- Format: Fireside Chat
- 2026 Cantor Global Healthcare Conference. New York, NY, Sept. 9-11, 2026.
- Format: Fireside Chat
Date, time: Thursday, Sept. 10, 1:00 p.m. EDT
- Format: Fireside Chat
- Morgan Stanley 24th Annual Global Healthcare Conference. New York, NY, Sept. 14-16, 2026.
- Format: Fireside Chat
Date, time: Tuesday, Sept. 15, 7:45 a.m. EDT
- Format: Fireside Chat
- H.C. Wainwright 28th Annual Global Investment Conference. New York, NY, Sept. 14-16, 2026.
- Format: Fireside Chat
Date, time: Wednesday, Sept. 16, 8:00 a.m. EDT
- Format: Fireside Chat
Live audio webcasts of the presentations will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replays will be available on Pharvaris’ website for 30 days following the presentation.
Upcoming Medical Congress Presentations
- Bradykinin Symposium 2026. Berlin, September 3-4, 2026. Details for the accepted presentations at the 8th Bradykinin Symposium are as follows:
- Title: Modelling human, rat, and humanized bradykinin B2 receptor-deucrictibant complexes in-silico
Presenter: Niklas Piet Doering, Ph.D.
Format: Oral Presentation
Abstract ID: 158012
Date, time: Thursday, September 3, 14:55-15:05 CEST (8:55-9:05 a.m. EDT) - Title: Oral Deucrictibant Immediate-Release Capsule for On-Demand Treatment of Hereditary Angioedema Attacks: Regional Subgroup Analysis From the Phase 3 RAPIDe-3 Trial
Presenter: Marc A. Riedl, M.D., M.S.
Format: Oral Presentation
Abstract ID: 158394
Date, time: Friday, September 4, 9:20-9:30 CEST (3:20-3:30 a.m. EDT) - Title: Clinical Cardiovascular Safety Evaluation of Oral Deucrictibant
Presenter: Brigitte Loenders, Ph.D.
Format: Poster Presentation
Abstract ID: 157799
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: Evaluating Safety Margins of the Use of Deucrictibant Immediate-Release Capsule in Combination With Deucrictibant Extended-Release Tablet
Presenter: Juan Bravo, Ph.D.
Format: Poster Presentation
Abstract ID: 157800
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: Results of the Phase 2 CHAPTER-1 Open-Label Extension Study on the Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema
Presenter: Emel Aygören-Pürsün, M.D.
Format: Poster Presentation
Abstract ID: 157804
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: CHAPTER-1 Open-Label Extension Study: Long-Term Prophylactic Treatment with Oral Deucrictibant Improved Health-Related Quality of Life in Participants with Hereditary Angioedema
Presenter: Marcin Stobiecki, M.D., Ph.D.
Format: Poster Presentation
Abstract ID: 157807
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: End Of Progression of Attack Manifestations With Oral Deucrictibant Immediate-Release Capsule for On-Demand Treatment of Hereditary Angioedema Attacks in the Phase 3 RAPIDe-3 Trial
Presenter: Henriette Farkas, M.D., Ph.D., D.Sc.
Format: Poster Presentation
Abstract ID: 158385
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: End-of-Progression Using Patient Global Impression of Change Validation in RAPIDe-3
Presenter: Danny M. Cohn, M.D., Ph.D.
Format: Poster Presentation
Abstract ID: 158405
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: LC-MS particle-based plasma proteomics in bradykinin-mediated angioedema
Presenter: Jonathan DeGeer, Ph.D.
Format: Poster Presentation
Abstract ID: 158979
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT) - Title: The NHP Bradykinin Challenge Model Predicts Human Deucrictibant Efficacious Doses
Presenter: Juan Bravo, Ph.D.
Format: Poster Presentation
Abstract ID: 159172
Date, time: Friday, September 4, 16:05-16:45 CEST (10:05-10:45 a.m. EDT)
- Title: Modelling human, rat, and humanized bradykinin B2 receptor-deucrictibant complexes in-silico
Financials
Second Quarter 2026 Financial Results
- Liquidity Position. Cash and cash equivalents were €318 million as of June 30, 2026, compared to €292 million for December 31, 2025.
- Research and Development (R&D) Expenses. R&D expenses were €35.0 million for the quarter ended June 30, 2026, compared to €29.6 million for the quarter ended June 30, 2025.
- General and Administrative (G&A) Expenses. G&A expenses were €15.8 million for the quarter ended June 30, 2026, compared to €10.8 million for the quarter ended June 30, 2025.
- Loss for the quarter. Loss for the second quarter was €47.8 million, resulting in basic and diluted loss per share of €0.70 for the quarter ended June 30, 2026, compared to €45.5 million, or basic and diluted loss per share of €0.83, for the quarter ended June 30, 2025.
Note on International Financial Reporting Standards (IFRS)
Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency.