-- 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 EUR318
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 ChatDate, time: Wednesday, Sept. 9, 4:30 p.m. EDT -- 2026 Cantor Global Healthcare Conference. New York, NY, Sept. 9-11, 2026. -- Format: Fireside ChatDate, time: Thursday, Sept. 10, 1:00 p.m. EDT -- Morgan Stanley 24th Annual Global Healthcare Conference. New York, NY, Sept. 14-16, 2026. -- Format: Fireside ChatDate, time: Tuesday, Sept. 15, 7:45 a.m. EDT -- H.C. Wainwright 28th Annual Global Investment Conference. New York, NY, Sept. 14-16, 2026. -- Format: Fireside ChatDate, time: Wednesday, Sept. 16, 8:00 a.m. EDT
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-silicoPresenter: Niklas Piet
Doering, Ph.D.Format: Oral PresentationAbstract ID: 158012Date,
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 TrialPresenter: Marc A. Riedl,
M.D., M.S.Format: Oral PresentationAbstract ID: 158394Date, time:
Friday, September 4, 9:20-9:30 CEST (3:20-3:30 a.m. EDT)
-- Title: Clinical Cardiovascular Safety Evaluation of Oral
DeucrictibantPresenter: Brigitte Loenders, Ph.D.Format: Poster
PresentationAbstract 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 TabletPresenter: Juan Bravo, Ph.D.Format: Poster
PresentationAbstract ID: 157800Date, 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 AngioedemaPresenter: Emel
Aygören-Pürsün, M.D.Format: Poster
PresentationAbstract ID: 157804Date, 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
AngioedemaPresenter: Marcin Stobiecki, M.D., Ph.D.Format: Poster
PresentationAbstract ID: 157807Date, 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
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