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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) 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.
Pharvaris (Nasdaq: PHVS) has appointed Joan Schmidt, J.D., as Chief Legal Officer, effective June 1, 2022. With over 20 years of biopharmaceutical experience, Schmidt will oversee legal activities supporting the company's drug development and commercialization strategies. Previously, she was General Counsel at Arena Pharmaceuticals, aiding in its acquisition by Pfizer for $6.7 billion. Her expertise will enhance Pharvaris' ability to advance its oral bradykinin-B2-receptor antagonists for hereditary angioedema (HAE) treatment.
Pharvaris (Nasdaq: PHVS) has achieved its target enrollment in the RAPIDe-1 Phase 2 study of PHVS416, focused on treating HAE attacks, with top-line data expected in 4Q22. Additionally, the company is enrolling patients in the Phase 2 HAE CHAPTER-1 study for prophylactic treatment, also anticipating data in 4Q22. Pharvaris reported a strong liquidity position with €194.8 million in cash as of March 31, 2022, though R&D and G&A expenses increased, leading to a loss of €16.0 million for Q1 2022.
Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on developing oral bradykinin-B2-receptor antagonists for treating hereditary angioedema (HAE), has announced its participation in the BofA Securities 2022 Healthcare Conference in Las Vegas from May 10-12, 2022. The company's presentation is scheduled for May 12, 2022, at 10:00 AM PDT (7:00 PM CEST). A live webcast will be accessible on its website, with a replay available for 30 days post-event.
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