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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.
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.
Pharvaris (Nasdaq: PHVS) presented preclinical and clinical data for its novel oral bradykinin B2 receptor antagonists, PHA121, PHVS416, and PHVS719, at the 2022 HAEi Global Leadership Workshop in Frankfurt, Germany. These treatments target hereditary angioedema (HAE) attacks, with PHVS416 designed for on-demand relief and PHVS719 for daily prophylaxis. Key findings indicate that PHA121 is 25-fold more potent than existing therapies, with promising pharmacokinetics for both formulations, offering rapid and sustained therapeutic effects in HAE management.
Pharvaris (Nasdaq: PHVS) announced the promotion of Annick Deschoolmeester to Chief Human Resources Officer. Ms. Deschoolmeester will manage talent acquisition, employee relations, and diversity initiatives. Her recent contributions are noted as vital for the company's strategic growth. She joined Pharvaris in September 2021, bringing over 25 years of HR experience, previously holding roles at Takeda Pharmaceuticals and other major firms. Pharvaris is focused on developing oral bradykinin-B2-receptor antagonists for treating hereditary angioedema (HAE).
Pharvaris (Nasdaq: PHVS) presented significant data on PHA121 at the Bradykinin Symposium 2022 in Berlin, supporting its development for hereditary angioedema (HAE) treatment. The clinical data demonstrate that PHA121 is 25-fold more potent than icatibant for inhibiting bradykinin interaction. The pharmacokinetics for PHVS416 provide therapeutic exposure within 30 minutes, while PHVS719 offers extended release for daily prophylaxis. Pharvaris aims to offer effective alternatives for HAE treatment through its drug development efforts.
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