• Topline data from CHAPTER-3, a pivotal study of deucrictibant for prophylactic treatment of HAE attacks, anticipated in 3Q2026
• Preparation of NDA dossier of deucrictibant for on-demand treatment of HAE attacks ongoing; timeline remains on-track for filing in 1H2026
• Recruitment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks
• Estimated cash runway into 1H2027

ZUG, Switzerland, Jan. 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 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.

Upcoming Participation at Investor Conferences

• Oppenheimer 36th Annual Healthcare Life Sciences Conference. Virtual, February 25-26, 2026.
  • Format: Fireside Chat
    Date, time: Thursday, February 26, 2026, 9:20-9:50 a.m. EST
• The Citizens Life Sciences Conference. Miami, FL, March 10-11, 2026.
  • Format: Fireside Chat
    Date, time: Tuesday, March 10, 2026, 11:20 a.m. EST
• Leerink Global Healthcare Conference 2026. Miami, FL, March 8-11, 2026.
  • Format: Fireside Chat
    Date, time: Wednesday, March 11, 2026, 9:20 a.m. EST

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 Presentations at Medical Congresses

• Western Society of Allergy, Asthma & Immunology (WSAAI) 63rd Annual Scientific Session. Wailea, HI, February 1-5, 2026. Details of the accepted presentation at WSAAI are as follows:
  • Title: Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema: Results of the Phase 2 CHAPTER-1 Open-Label Extension Study
    Presenter: Michael E. Manning, M.D.
    Date, time: Wednesday, February 4, 2026, 7:00-8:00 a.m. HST (12:00-1:00 p.m. EST) and 11:30 a.m.-12:00 p.m. HST (4:30-5:00 p.m. EST)
• American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting. Philadelphia, PA, February 27-March 2, 2026. Details for the accepted presentations at AAAAI are as follows:
  • Title: A Novel Kinin Biomarker Assay for Characterization of Different Types of Bradykinin-Mediated Angioedema
    Presenter: Evangelia Pardali, Ph.D.
    Poster Number: 078
    Date, time: Friday, February 27, 2026, 2:45-3:45 p.m. EST
  • Title: Content Validity of the Angioedema syMptom Rating scAle (AMRA) to Assess Symptoms of Hereditary Angioedema Attacks
    Presenter: Teresa Caballero, M.D., Ph.D.
    Poster Number: 154
    Date, time: Friday, February 27, 2026, 2:45-3:45 p.m. EST
  • Title: Long-Term Prophylactic Treatment with Oral Deucrictibant Improved Health-Related Quality of Life in Participants with Hereditary Angioedema: Final Results of the Phase 2 CHAPTER-1 Open-Label Extension Study
    Presenter: Michael E. Manning, M.D.
    Poster Number: 159
    Date, time: Friday, February 27, 2026, 2:45-3:45 p.m. EST
  • Title: Oral Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks: Results of the Phase 3 RAPIDe-3 Study
    Presenter: Marc A. Riedl, M.D., M.S.
    Featured Poster Number: 831
    Date, time: Sunday, March 1, 2026, 3:30-5:00 p.m. EST
  • Title: Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema: Final Results of the Phase 2 CHAPTER-1 Open-Label Extension Study
    Presenter: John Anderson, M.D.
    Featured Poster Number: 832
    Date, time: Sunday, March 1, 2026, 3:30-5:00 p.m. EST
  • Title: Sustained Therapeutic Exposure with Once-Daily Oral Deucrictibant Extended-Release Tablet for Prophylaxis of Hereditary Angioedema Attacks
    Presenter: Zhi-Yi Zhang, Ph.D.
    Featured Poster Number: 834
    Date, time: Sunday, March 1, 2026, 3:30-5:00 p.m. EST
    

The posters will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations.

About Deucrictibant
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic.

About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing global marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, visit https://pharvaris.com/.

Contact
Maggie Beller
Executive Director, Head of Corporate and Investor Communications
maggie.beller@pharvaris.com

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