Timeline for submission of NDA of deucrictibant IR for the on-demand treatment of HAE attacks remains on-track in 1H2026
Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks
Cash and cash equivalents of €247 million as of March 31, 2026; subsequent closing of $132 million underwritten offering extends cash runway into 2028
ZUG, Switzerland, May 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 diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the first quarter ended in March 31, 2026, and provided a business update.
"In 2026, Pharvaris remains focused on execution across our late-stage programs, including reporting CHAPTER-3 data in the third quarter and enrolling in CREAATE, and on establishing our commercial infrastructure in preparation for the potential launch of deucrictibant IR," said Berndt Modig, Chief Executive Officer of Pharvaris. "The growing published scientific evidence of deucrictibant's potential as an end-to-end portfolio solution for bradykinin-mediated angioedema care supports our clinical, regulatory, and commercial strategies. Supported by the upsized and oversubscribed raise of approximately $132 million, our team is maintaining a disciplined approach to capital allocation that prioritizes the success of deucrictibant."
Recent Business UpdatedDevelopment Pipeline
Topline data from CHAPTER-3 (NCT06669754) anticipated 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. Approximately 81 participants were enrolled and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which is the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing 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 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.
Submission of New Drug Application (NDA) of deucrictibant immediate release (IR) capsule for the on-demand treatment of HAE attacks remains on-track for 1H2026. Data from the pivotal, randomized, placebo-controlled Phase 3 study, RAPIDe-3, and the long-term extension study, RAPIDe-2, will serve as the basis for the NDA of deucrictibant IR, which is on-track for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2026.
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.
Recent data publications and presentations report evidence on the potential for combined use of bradykinin B2 receptor antagonism for both prophylactic and on-demand treatment of HAE attacks. Evidence supporting the use of deucrictibant IR as an on-demand treatment in the event of a breakthrough attack in combination with deucrictibant XR as a prophylactic treatment were recently presented at the CIIC ...
