Pharvaris outlines 2026 strategic priorities

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 outlined its strategic priorities for 2026.

“The readout of Pharvaris’ first pivotal Phase 3 study, RAPIDe-3, in December was the culmination of a decade of scientific rigor, operational and financial diligence, executional excellence, and, most importantly, community engagement and commitment,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The data reported in December build upon Pharvaris’ legacy in HAE drug development, and we believe demonstrate deucrictibant’s potentially differentiated profile and potential to become a new standard of care for on-demand HAE treatment of attacks. Our team’s ability to conduct the most diverse Phase 3 on-demand study in HAE, by including previously underserved regions and subgroups, and improve upon the outcomes of the RAPIDe-1 Phase 2 study further bolsters our confidence in the clinical execution of the CHAPTER-3 prophylactic study, for which the timing of anticipated data readout has now been refined to the third quarter of 2026.”

2026 Strategic Priorities
Long-term Prophylaxis of HAE Attacks

• 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 tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants randomized in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of 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 extended-release tablet (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 extended-release tablet in the prophylactic treatment of HAE attacks.
• Completed CHAPTER-1 (NCT05047185); final data recently presented. Final Results from the randomized portion and the long-term open-label portion of the study demonstrated that deucrictibant was well tolerated for up to approximately three years. The mean rate of HAE attacks was reduced by deucrictibant within the first week of treatment and remained low for up to approximately 34 months, with an overall mean monthly on-treatment attack rate of 0.12 throughout the completed open-label extension portion of the study.

On-demand Treatment of HAE Attacks

• RAPIDe-3 (NCT06343779) met primary endpoint and all secondary efficacy endpoints with statistical significance. Outcomes from RAPIDe-3, a pivotal global Phase 3 study evaluating orally administered deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), confirming the potential of deucrictibant’s differentiated profile for the on-demand treatment of HAE attacks. The primary endpoint, median time to onset of symptom relief, was achieved in 1.28 hours, significantly faster versus placebo (p<0.0001), and deucrictibant was well tolerated. Pharvaris plans to present additional efficacy, safety, and patient experience data at upcoming medical congresses.
• Filing of U.S. New Drug Application (NDA) of deucrictibant for the on-demand treatment of HAE attacks anticipated 1H2026. Pharvaris is preparing the dossier for deucrictibant’s NDA filing. The data from RAPIDe-3 and RAPIDe-2 will serve as the basis for marketing authorization applications, which are planned to be filed starting in the first half of 2026.

Clinical Development of Deucrictibant in AAE-C1 INH

• CREAATE (NCT06669754) study progressing as planned. Pharvaris initiated CREAATE, a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, in November 2025. CREAATE assesses the efficacy and safety of deucrictibant in people living with AAE-C1INH. In part 1 of CREAATE, participants receive either deucrictibant extended-release tablet (40 mg) or placebo once daily for the prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants treat two attacks in a cross-over fashion, one attack with deucrictibant immediate-release capsule (20 mg) and one with placebo according to a randomized treatment sequence, for the on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study assessing the long-term safety and effectiveness of deucrictibant immediate-release capsule (20 mg) for on-demand treatment.

Business Updates
Corporate

• Cash runway into 1H2027. Pharvaris remains diligent in its operational management and is focusing on late-stage clinical development programs and commercial preparedness for the potential launch of deucrictibant.
• Pharvaris recently added to Nasdaq Biotechnology Index (NBI). In December 2025, Pharvaris was added to the NBI. Companies in the NBI must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. The NBI is evaluated annually in December and is calculated under a modified capitalization-weighted methodology.