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Pharvaris N.V. (PHVS) news centers on its progress as a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists for bradykinin-mediated angioedema. Company updates frequently highlight clinical milestones for its lead candidate deucrictibant, including pivotal Phase 3 programs in hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH).
Investors following PHVS news can expect detailed announcements on clinical trial results and timelines. Recent releases describe RAPIDe-3, a pivotal global Phase 3 study of deucrictibant immediate-release capsule for on-demand treatment of HAE attacks, which met its primary endpoint and all secondary efficacy endpoints with statistical significance and was reported as well tolerated. Other updates cover CHAPTER-3 and CHAPTER-4, Phase 3 studies of the extended-release tablet for long-term prophylaxis of HAE attacks, and CHAPTER-1 Phase 2 data showing sustained reductions in attack rates over long-term treatment.
Pharvaris news also includes information on the CREAATE Phase 3 study in AAE-C1INH, presentations of deucrictibant data at major medical congresses, and summaries of biomarker work such as the kinin assay being clinically validated to characterize bradykinin-mediated angioedema. Financial and corporate updates, including quarterly results, cash runway commentary, and details of public offerings of ordinary shares and pre-funded warrants, are furnished through press releases and Form 6-K filings.
For readers tracking PHVS, this news stream provides insight into the advancement of deucrictibant’s prophylactic and on-demand indications, regulatory filing plans such as the preparation of marketing authorization applications, and the company’s broader efforts in bradykinin-mediated diseases.
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Pharvaris (Nasdaq: PHVS) reported its financial results for Q4 and full year 2022, revealing a loss of €39.2 million for Q4 and a total loss of €76.3 million for the year. Cash and equivalents stood at €162 million as of December 31, 2022. Upcoming milestones include the release of top-line data from the CHAPTER-1 Phase 2 study of PHVS416 for hereditary angioedema (HAE), expected in 2H2023, and the completion of a non-clinical toxicology study by YE2023. The company has also adopted deucrictibant as the nonproprietary name for PHA121.
Pharvaris (Nasdaq: PHVS) announced positive results from its Phase 2 RAPIDe-1 trial of PHVS416 for treating hereditary angioedema (HAE) at the 2023 HAEi Regional Conference APAC. The trial, which included 74 participants and evaluated 147 HAE attacks, demonstrated significant symptom reduction at four hours post-treatment with PHVS416 compared to placebo, achieving a nominal p-value <0.0001. All primary and key secondary endpoints were met, with participants using less rescue medication. PHVS416 was well tolerated, with minimal treatment-related adverse events. These findings support ongoing development as a potential oral on-demand therapy for HAE attacks.
ZUG, Switzerland, March 02, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS) announced participation in two investor conferences in March. The first event is the BioCapital Europe 2023, taking place in Amsterdam on March 9, 2023, at 11:00 a.m. CET. The second is the Oppenheimer 33rd Annual Healthcare Conference, a virtual presentation scheduled for March 13, 2023, at 2:00 p.m. CET. A live audio webcast of the latter will be accessible on Pharvaris' website, with a replay available for 30 days. Pharvaris specializes in developing oral bradykinin-B2-receptor antagonists for treating hereditary angioedema (HAE), aiming to provide effective treatment options.
Pharvaris (Nasdaq: PHVS) announced positive data from its Phase 2 RAPIDe-1 study of PHVS416, an oral bradykinin-B2-receptor antagonist for hereditary angioedema (HAE), presented at the AAAAI Annual Meeting in February 2023. The trial enrolled 74 participants, showing that PHVS416 significantly improved symptoms during HAE attacks, reducing the mean 3-symptom composite score (p<0.0001). Participants required less rescue medication when on PHVS416 versus placebo. The results support further development of PHVS416 as an on-demand therapy for HAE.
Pharvaris aims to offer effective, convenient treatment options for HAE patients worldwide.
Pharvaris (Nasdaq: PHVS), a clinical-stage company, is focused on developing oral bradykinin-B2-receptor antagonists for treating and preventing hereditary angioedema (HAE) attacks. The company announced its participation in the SVB Securities Global Biopharma Conference, scheduled virtually from February 14–16, 2023. Pharvaris will present on February 15, at 2:40 p.m. CEST (8:40 a.m. EST), with a live audio webcast accessible on their Investor page. A replay will be available for 30 days post-presentation. Pharvaris aims to provide safe and effective treatment options for all HAE sub-types, leveraging its specialized knowledge in rare diseases.
Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on oral bradykinin-B2-receptor antagonists for hereditary angioedema (HAE), provided key business updates. The FDA received meeting minutes and will require a 26-week rodent toxicology study to resolve clinical holds. Positive top-line data from RAPIDe-1 was released in December 2022, with the FDA allowing final U.S. participant dosing. Top-line data from the CHAPTER-1 Phase 2 study is expected in 2H2023. The company maintains a cash runway into 4Q2024.
Pharvaris (PHVS) announced positive top-line data from the Phase 2 RAPIDe-1 study, showing significant efficacy of PHVS416 as an oral treatment for hereditary angioedema (HAE) attacks. The company is actively resolving clinical holds on PHA121 in the U.S. following a Type A meeting with the FDA. Pharvaris holds €198 million in cash as of September 30, 2022, although R&D expenses increased to €14.1 million. Future top-line data from CHAPTER-1, another Phase 2 study, is expected in the second half of 2023, aiming to evaluate PHVS416 prophylactically.
Pharvaris (Nasdaq: PHVS) announced positive results from the RAPIDe-1 Phase 2 clinical study of PHVS416, a novel oral treatment for hereditary angioedema (HAE). Key findings include:
- The primary endpoint was met, showing significant symptom relief.
- All secondary endpoints were achieved, demonstrating rapid onset and efficacy.
- PHVS416 was well tolerated across all dose levels.
Overall, the study indicates PHVS416's potential as an effective on-demand therapy for HAE attacks.
Pharvaris (Nasdaq: PHVS) has announced its participation in the ACAAI Annual Scientific Meeting 2022, taking place from November 10-14, 2022. The company will present two ePosters, highlighting promising pharmacokinetic profiles of its investigational drugs PHVS719 and PHVS416 for hereditary angioedema (HAE). PHVS719 aims for once-daily prophylactic treatment, demonstrating sustained therapeutic levels. Key presentations will showcase pharmacokinetic data and tolerability results, with no severe adverse events reported during early clinical trials.