Pharvaris NV is a clinical-stage company, which engages in bringing oral bradykinin B2-receptor antagonists to patients. It focuses on the development and commercialization of innovative therapies for rare diseases focused on angioedema and other bradykinin-mediated diseases. The company was founded by Luc Dochez, Jens Schneider-Mergener, Berndt A. E. Modig, Jochen Knolle, Johannes Gerardus Christiaan Petrus Schikan, and Anne Lesage on September 30, 2015 and is headquartered in Leiden, the Netherlands.
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- BRAIN Biotech AG received a EUR 11.51 million milestone payment from Royalty Pharma tied to a key development milestone for the investigational compound deucrictibant. - The payment stems from a monetization agreement regarding licensing rights dated September 20, 2024, and raises the likelihood of additional future milestone payments totaling up to EUR 96.65 million. - Positive results from the CHAPTER-3 study for deucrictibant significantly increased the probability of future regulatory and commercial milestone payments, according to CFO Michael Schneiders. - A remeasurement of liabilities under IFRS 9 may result in a one-time, non-cash charge of up to EUR 28 million, which the company expects to be fully offset over the agreement's term.
- Once-daily deucrictibant extended-release tablets reduced hereditary angioedema attack rates by 83% versus placebo in the Phase 3 CHAPTER-3 trial, with a p-value below 0.0001. - The global, double-blind study randomized 85 adolescents and adults across 21 countries to 40 mg deucrictibant XR or placebo for 24 weeks, with all secondary endpoints met. - Pharvaris plans to submit a prophylaxis New Drug Application to the FDA in the first half of 2027, following an accepted NDA for the immediate-release formulation. - Deucrictibant blocks the bradykinin B2 receptor, potentially making it the first oral HAE therapy spanning both on-demand treatment and long-term prophylaxis.
- Pharvaris announced positive topline data from its RAPIDe-3 pivotal Phase 3 study, with deucrictibant achieving median time to symptom relief in 1.28 hours versus over 12 hours for placebo. - The global study enrolled 134 participants across 24 countries, representing the most diverse patient population in an on-demand HAE trial, with efficacy consistent across all HAE subtypes. - All secondary efficacy endpoints were met, including End of Progression at 17.47 minutes and complete symptom resolution at 11.95 hours, with no treatment-related serious adverse events. - Pharvaris plans to submit a New Drug Application to the FDA in the first half of 2026 for this oral bradykinin B2 receptor antagonist.
- The FDA approved three new hereditary angioedema treatments in just three months during 2025: CSL's Andembry in June, KalVista's Ekterly in July, and Ionis's Dawnzera in August. - These approvals represent breakthrough innovations including the first factor XIIa inhibitor, first oral on-demand therapy, and first RNA-targeting treatment for HAE prevention. - The rapid succession of approvals brings the total number of FDA-approved HAE treatments from 9 to 12, offering unprecedented treatment options for the estimated 7,000 U.S. patients. - Despite the therapeutic advances, significant unmet needs remain, particularly for pediatric patients under 12 years old, as 85% of HAE patients develop symptoms before age 20.
- Pharvaris presented long-term clinical data at ACAAI 2025 showing deucrictibant achieved a sustained 92.4% reduction in hereditary angioedema attacks over nearly three years. - The company also validated a plasma kinin biomarker assay that may help further characterize bradykinin-mediated angioedema and support clinical development. - Pharvaris reported a net loss of €37.14 million for Q3 2025 while advancing toward pivotal Phase 3 trial readouts for RAPIDe-3 in late 2025 and CHAPTER-3 in 2026. - The positive clinical results have strengthened investor confidence in deucrictibant's potential for treating hereditary angioedema despite ongoing financial losses.
- DelveInsight's 2025 pipeline report reveals over 20 companies are actively developing more than 30 therapeutic candidates for hereditary angioedema treatment across various clinical stages. - Recent clinical developments include CSL Behring's Phase 3b study of garadacimab (CSL312) announced in August 2025 and KalVista's pediatric trial of KVD900 for patients aged 2-11 years. - Leading pipeline therapies span multiple approaches including oral plasma kallikrein inhibitors, gene therapies, and monoclonal antibodies, with products in late-stage development showing promise for addressing unmet medical needs.
- NodThera has appointed Elisabeth Björk, M.D., Ph.D., former Senior Vice President at AstraZeneca's obesity franchise, to its Board of Directors. - The appointment follows the commencement of NodThera's Phase 2 RESOLVE-1 trial evaluating oral NLRP3 inflammasome inhibitor NT-0796 in patients with obesity. - Björk brings over 20 years of experience in late-stage clinical development and commercialization, particularly in cardiovascular and metabolic diseases. - NodThera is developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases through selective modulation of metabolic pathways.
- The European Commission has granted orphan designation to Pharvaris' investigational drug deucrictibant for treating bradykinin-mediated angioedema, following similar FDA designation in 2022. - Deucrictibant, an oral bradykinin B2 receptor antagonist, is currently in Phase 3 clinical trials for hereditary angioedema (HAE) with potential to address broader bradykinin-mediated angioedema conditions. - Pharvaris is developing two oral formulations of deucrictibant: an extended-release tablet for prophylactic treatment and an immediate-release capsule for on-demand therapy of angioedema attacks.
• Pharvaris's oral drug deucrictibant demonstrated strong efficacy in Phase 3 studies, with patients experiencing a median of zero attack days per month during long-term prophylactic treatment. • The medication showed consistent safety and efficacy in treating both upper airway and non-upper airway HAE attacks, with rapid and complete symptom resolution using a single dose. • Clinical data revealed significant improvements in patients' quality of life, particularly in functioning and psychological aspects, addressing key concerns in the HAE community.
2024 marked significant advances in hereditary angioedema (HAE) treatment, with Intellia's gene-editing therapy NTLA-2002 showing a remarkable 95% reduction in monthly attacks. The year also saw important developments in multiple therapeutic candidates, including donidalorsen and garadacimab, while established treatments like Takhzyro demonstrated continued efficacy in adolescent populations.
