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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), a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE), announced the acceptance of 12 abstracts for presentation at the 7th Bradykinin Symposium in Berlin, Germany, from September 5-6, 2024. The presentations include two oral presentations and ten poster presentations covering various aspects of their lead compound, deucrictibant.
The presentations will showcase clinical, real-world, nonclinical, and discovery data on deucrictibant, including its efficacy in HAE prophylaxis, treatment of HAE attacks, long-term safety, and cardiovascular safety. The symposium will also feature presentations on novel biomarker assays and preclinical models for bradykinin-mediated disorders.
Pharvaris (PHVS) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Alignment with regulatory agencies on the CHAPTER-3 Phase 3 study design for deucrictibant as a prophylactic HAE treatment
- Progression of RAPIDe-3 Phase 3 study for on-demand HAE attack treatment
- Strong financial position with €344 million in cash as of June 30, 2024
- Q2 2024 R&D expenses of €23.1 million, up from €14.7 million in Q2 2023
- Net loss of €29.7 million for Q2 2024, or €0.55 per share
The company continues to focus on executing its clinical studies to establish differentiated data packages for deucrictibant in both on-demand and prophylactic HAE treatment.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company, announced its annual general meeting of shareholders will be held on June 28, 2024, at 15:00 CEST (9:00 a.m. EDT).
The company focuses on developing novel, oral bradykinin B2 receptor antagonists for treating and preventing hereditary angioedema (HAE) attacks.
All pertinent documents and information for the meeting are accessible on Pharvaris’ website under the 'Investors' section, as well as on the SEC’s website. Shareholders interested in attending must register according to the instructions provided in the meeting notice and agenda.
Pharvaris (Nasdaq: PHVS) recently presented data on their oral bradykinin B2 receptor antagonist, deucrictibant, at several congresses. The data from the Phase 2 RAPIDe-1 study showed that a single dose of deucrictibant resolved symptoms of hereditary angioedema (HAE) attacks in 78.6% of participants within 24 hours, compared to 22.4% for placebo. The Phase 2 CHAPTER-1 study found that treatment satisfaction with deucrictibant was higher than placebo and on par with high-efficacy injectable treatments. Pharvaris expects to publish more data from ongoing open-label extensions to further validate the long-term safety and efficacy of deucrictibant. The company aims to position deucrictibant as a best-in-class treatment for HAE and is exploring additional indications and pipeline expansions.
Pharvaris, a late-stage biopharmaceutical company, will present clinical and nonclinical data at three upcoming congresses focusing on their oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks. The abstracts will cover topics like pharmacological profiles, relief of attack symptoms, efficacy, and safety of their treatments. The company aims to showcase their developments in the field and highlight the positive outcomes of their trials.
Pharvaris, a late-stage biopharmaceutical company with the stock symbol PHVS, reported strong financials with €368 million in cash, executing pivotal Phase 3 studies for HAE treatment, and preparing for commercial launch. The company's loss for Q1 2024 was €28.0 million, with R&D expenses at €18.5 million and G&A expenses at €9.8 million.
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