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Pharvaris N.V. (PHVS) is a pioneering, clinical-stage biopharmaceutical company dedicated to developing novel, oral bradykinin B2 receptor antagonists for the treatment and prevention of hereditary angioedema (HAE) and other related conditions. With a strategic focus on unmet medical needs in rare diseases, Pharvaris aims to provide safer, more effective, and easier-to-administer alternatives to currently available injectable therapies.
Core Business and Expertise
Pharvaris is spearheaded by a team with profound expertise in HAE, including the discovery and approval of the HAE treatment icatibant. The company leverages this foundation to develop small, potent molecules targeting the bradykinin B2 receptor—a clinically validated therapeutic target. By inhibiting bradykinin signaling at this receptor, Pharvaris' lead candidate, deucrictibant, offers potential for both acute and prophylactic treatment of HAE and other bradykinin-mediated diseases.
Current Projects and Achievements
- Pharvaris has made significant progress in its clinical development programs. Notably, the U.S. FDA has lifted the clinical hold on deucrictibant, allowing the continuation of global development, including Phase 2 and Phase 3 trials.
- The company's Phase 2 CHAPTER-1 study demonstrated positive top-line data for deucrictibant in preventing HAE attacks, with significant reductions in attack rates at both 20 mg/day and 40 mg/day doses.
- Deucrictibant is being developed in two formulations: a rapid-onset capsule for acute treatment and an extended-release tablet for long-term prophylaxis.
Future Outlook
Pharvaris is preparing for the global Phase 3 CHAPTER-3 study and continues to engage with regulatory authorities to align on study designs. The company is also expanding its research into other bradykinin-mediated conditions, aiming to broaden its therapeutic portfolio.
Financial Condition and Market Presence
Strong financial performance and strategic investor support underscore Pharvaris’ potential. The company’s financial health allows it to fund ongoing and future clinical trials while building infrastructure for the anticipated launch of deucrictibant. Pharvaris is committed to operating transparently, with regular updates provided to its stakeholders through its website and regulatory filings.
With a clear mission to transform the treatment landscape for rare diseases, Pharvaris stands out for its innovative approach and dedication to improving patient outcomes.
Pharvaris (Nasdaq: PHVS) presented clinical data supporting the safety and pharmacokinetic profile of PHA121 for hereditary angioedema (HAE) at the EAACI Annual Congress 2021. In a double-blind, placebo-controlled study involving 38 healthy volunteers, PHA121 was well-tolerated, with all treatment-emergent adverse events classified as mild. The drug demonstrated dose-proportional absorption with steady-state plasma levels achieved within three days. Pharvaris aims to develop PHA121 into an effective oral treatment for HAE alongside formulations PHVS416 and PHVS719.
Pharvaris (Nasdaq: PHVS) announced the presentation of clinical data for oral PHA121, a bradykinin B2 receptor antagonist for hereditary angioedema (HAE), at the EAACI Annual Congress 2021, from July 10-16. The e-Poster will detail the pharmacokinetic profile and tolerability of PHA121 in multiple dose administration. The abstract will be available on the EAACI website on July 10. Pharvaris focuses on developing oral treatments for HAE, aiming to provide alternatives to injected therapies.
Pharvaris (Nasdaq: PHVS) announced its annual general meeting of shareholders scheduled for June 29, 2021, at 1:00 p.m. CEST. Relevant documents, including the notice and agenda, will be accessible in the 'Investors' section of Pharvaris’ website and on the SEC’s site. Pharvaris is focused on developing oral bradykinin-B2-receptor antagonists aimed at treating hereditary angioedema (HAE) and related conditions, offering alternatives to injected therapies. The company's leadership comprises experts in pharmaceutical development and rare disorders.
Pharvaris (Nasdaq: PHVS) announced at the 12th C1 Inhibitor Deficiency and Angioedema Workshop that its compound PHA121 demonstrates superior pharmacokinetic and pharmacodynamic profiles compared to icatibant for hereditary angioedema (HAE) treatment. Dr. Anne Lesage highlighted findings from bradykinin challenge data indicating faster onset and longer duration of effect. Pharvaris is advancing PHA121 for both on-demand and prophylactic treatments, with formulations PHVS416 and PHVS719 in various stages of clinical development.
Pharvaris (PHVS) reported a strong financial position with cash and equivalents of €238.3 million as of March 31, 2021. The company is advancing its Phase 2 studies for PHVS416, an oral treatment for hereditary angioedema (HAE), with the RAPIDe-1 on-demand study underway and the HAE CHAPTER-1 prophylactic study set to initiate in 2021. The leadership team has expanded with the appointment of Wim Souverijns as chief community engagement & commercial officer and the nomination of Viviane Monges to the Board of Directors.
Pharvaris (Nasdaq: PHVS) has appointed Wim Souverijns, Ph.D., as Chief Community Engagement & Commercial Officer, effective July 1, 2021. With over 25 years of experience in pharmaceutical leadership, Souverijns will enhance Pharvaris' engagement with the HAE community and support the commercialization of PHVS416 and PHVS719. This strategic appointment aims to bolster the company's clinical development programs and market readiness for its oral bradykinin-B2-receptor antagonists. Pharvaris focuses on innovative treatments for hereditary angioedema (HAE).
Pharvaris (Nasdaq: PHVS) announced key updates regarding its clinical pipeline and financial standing as of December 31, 2020. The company is actively enrolling patients in the Phase 2 RAPIDe-1 clinical trial for PHVS416, an oral therapy for hereditary angioedema (HAE). Pharvaris has a robust cash position of €98.6 million following its IPO, enabling continued research and development efforts, including upcoming prophylactic studies of PHVS416 and PHVS719. Despite a net loss of €26.0 million for 2020, the company remains optimistic about advancing treatments for HAE.
Pharvaris (Nasdaq: PHVS) announced the FDA's acceptance of its Investigational New Drug (IND) application for PHVS416, an oral bradykinin-B2-receptor antagonist aimed at treating hereditary angioedema (HAE). This milestone paves the way for a prophylactic study, complementing the ongoing Phase 2 clinical trial for on-demand treatment. PHVS416 offers a softgel formulation of the previously studied PHA121, which has shown promising results in earlier trials. Pharvaris aims to provide effective oral alternatives for HAE patients.
Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on oral bradykinin-B2-receptor antagonists for hereditary angioedema (HAE), announced CEO Berndt Modig's participation in BioCapital Europe. The event will feature a panel presentation titled “Shaping the New Biotech Reality – Key Lessons from COVID” on March 10, 2021, at 18:30 CET. Additionally, a corporate presentation will occur on March 11, 2021, at 14:50 CET. Both presentations will be accessible for 30 days on the Pharvaris website.
Pharvaris (Nasdaq: PHVS) has initiated the RAPIDe-1 Phase 2 study, dosing the first patient for its oral bradykinin B2 receptor antagonist, PHVS416, targeting hereditary angioedema (HAE) treatment. The trial will evaluate the efficacy, safety, and pharmacokinetics of PHVS416 in 54 adult patients with HAE type 1 or 2 across North America and Europe. The results aim to provide rapid and convenient on-demand treatment for HAE attacks, offering an alternative to injectable therapies. Pharvaris' approach could significantly enhance patient care for this rare condition.
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