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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.
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.
Pharvaris (Nasdaq: PHVS) announced the receipt of formal letters from the FDA regarding a clinical hold on PHA121 studies in the U.S., necessitating additional long-term studies. Top-line data from the global Phase 2 RAPIDe-1 study of PHVS416 for hereditary angioedema (HAE) attacks is expected in 4Q22. As of June 30, 2022, the company reported cash and equivalents of €201 million, down from €209 million at year-end 2021. R&D and G&A expenses rose significantly to €13.7 million and €7.7 million respectively, while the loss for Q2 2022 was €12.6 million, down from €15.2 million a year earlier.
Pharvaris (Nasdaq: PHVS) announced a clinical hold by the FDA on trials for PHA121, a treatment for hereditary angioedema (HAE). The hold is due to the FDA's review of nonclinical data, with a formal letter expected in 30 days. CEO Berndt Modig emphasized the company's commitment to addressing the FDA's concerns and continuing its work on developing new therapies for HAE. This setback raises questions about the progress of their clinical trials for PHA121, PHVS416, and PHVS719, which are currently on hold.
Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on treating hereditary angioedema (HAE), will participate in a fireside chat at the H.C. Wainwright 1st Annual HAE Conference on July 20, 2022, at 1:30 PM EDT. This virtual event aims to discuss Pharvaris' novel oral bradykinin-B2-receptor antagonists. A live webcast will be accessible on their website, with a replay available for 30 days post-event.
Pharvaris targets effective treatment alternatives for HAE, leveraging their deep industry expertise.
Pharvaris (Nasdaq: PHVS), a clinical-stage company, announced a virtual webinar on July 13, 2022, titled Expert Perspectives on HAE: Unmet Needs and Therapeutic Options. The event will address the current landscape of Hereditary Angioedema (HAE), featuring insights from community members and physicians. Key speakers include Anthony J. Castaldo from HAE International, Dr. Marc A. Riedl from UCSD, Berndt Modig, and Dr. Peng Lu from Pharvaris. Registration for the live webcast is available on their website, with an archived replay accessible for 30 days post-event.
Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on oral bradykinin-B2-receptor antagonists for hereditary angioedema (HAE), announced its annual general meeting of shareholders on June 29, 2022, at 16:00 CEST (10:00 a.m. EDT). Meeting details, including the agenda and relevant documents, will be available in the Investors section of its website and the SEC’s website. Pharvaris aims to provide more effective treatments for all HAE sub-types, leveraging its expertise in rare diseases.
Pharvaris (Nasdaq: PHVS) presented its drug development approach for treating hereditary angioedema (HAE) at the Kinin 2022 Conference in France. The symposium highlighted PHVS416 and PHVS719, two oral therapies designed for on-demand and prophylactic treatment. Key findings showed PHVS416 is 25-fold more potent than icatibant, with rapid onset and longer half-life. The Phase 2 RAPIDe-1 study for PHVS416 has reached target enrollment, while the Phase 2 CHAPTER-1 trial continues. Pharvaris aims to provide better treatment alternatives for HAE patients.
Pharvaris (Nasdaq: PHVS) announced its participation in the hae day :-) 2022, a global awareness initiative for hereditary angioedema (HAE). The company engaged its workforce in a 30-day activities challenge, collectively logging over 2 million steps to raise awareness for HAE. CEO Berndt Modig emphasized the company's commitment to improving outcomes for HAE patients through innovative treatments. HAE is a rare genetic condition affecting between 1:50,000 to 1:10,000 individuals globally, causing unpredictable and often life-threatening swelling.