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Pharvaris N.V. Ordinary Shares - PHVS STOCK NEWS

Welcome to our dedicated page for Pharvaris N.V. Ordinary Shares news (Ticker: PHVS), a resource for investors and traders seeking the latest updates and insights on Pharvaris N.V. Ordinary Shares stock.

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.

Rhea-AI Summary
Pharvaris (Nasdaq: PHVS) completed enrollment in Phase 2 CHAPTER-1 prophylactic study with top-line data anticipated by YE2023. The clinical hold on deucrictibant for the on-demand treatment of HAE was lifted, with initiation of global Phase 3 clinical study (RAPIDe-3) anticipated by YE2023. Additionally, a $70 million private placement was completed, resulting in cash and cash equivalents of €179 million as of June 30, 2023.
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Pharvaris shares data from the RAPIDe-1 Phase 2 clinical study of PHVS416 for the treatment of hereditary angioedema attacks.
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Pharvaris (Nasdaq: PHVS) reported its financial results for Q4 and full year 2022, revealing a loss of €39.2 million for Q4 and a total loss of €76.3 million for the year. Cash and equivalents stood at €162 million as of December 31, 2022. Upcoming milestones include the release of top-line data from the CHAPTER-1 Phase 2 study of PHVS416 for hereditary angioedema (HAE), expected in 2H2023, and the completion of a non-clinical toxicology study by YE2023. The company has also adopted deucrictibant as the nonproprietary name for PHA121.

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Pharvaris (Nasdaq: PHVS) announced positive results from its Phase 2 RAPIDe-1 trial of PHVS416 for treating hereditary angioedema (HAE) at the 2023 HAEi Regional Conference APAC. The trial, which included 74 participants and evaluated 147 HAE attacks, demonstrated significant symptom reduction at four hours post-treatment with PHVS416 compared to placebo, achieving a nominal p-value <0.0001. All primary and key secondary endpoints were met, with participants using less rescue medication. PHVS416 was well tolerated, with minimal treatment-related adverse events. These findings support ongoing development as a potential oral on-demand therapy for HAE attacks.

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FAQ

What is the current stock price of Pharvaris N.V. Ordinary Shares (PHVS)?

The current stock price of Pharvaris N.V. Ordinary Shares (PHVS) is $18.06 as of January 6, 2025.

What is the market cap of Pharvaris N.V. Ordinary Shares (PHVS)?

The market cap of Pharvaris N.V. Ordinary Shares (PHVS) is approximately 1.0B.

What is Pharvaris N.V. focused on?

Pharvaris N.V. is focused on developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) and other bradykinin-mediated diseases.

What is deucrictibant?

Deucrictibant is a potent, selective, and orally available antagonist of the bradykinin B2 receptor developed by Pharvaris for the treatment and prevention of HAE attacks.

What recent achievements has Pharvaris made?

Pharvaris has announced positive top-line data from the Phase 2 CHAPTER-1 study and received FDA approval to lift the clinical hold on deucrictibant, allowing the continuation of global development.

What clinical trials are ongoing at Pharvaris?

Pharvaris is conducting Phase 2 and Phase 3 clinical trials, including the CHAPTER-1 and CHAPTER-3 studies, to evaluate the efficacy and safety of deucrictibant in treating and preventing HAE attacks.

What makes deucrictibant unique?

Deucrictibant offers the potential for both rapid-onset and extended-release formulations, providing patients with effective oral alternatives to injectable therapies for HAE.

How is Pharvaris positioned financially?

Pharvaris is financially strong, with investor support enabling the advancement of its clinical programs and preparation for the commercial launch of deucrictibant.

What is the significance of Pharvaris' focus on oral therapies?

Oral therapies like deucrictibant aim to improve patient convenience and compliance, offering a more manageable and less invasive option compared to injectable treatments.

What are Pharvaris' future plans?

Pharvaris plans to continue its clinical trials, engage with regulatory authorities, and expand research into other bradykinin-mediated diseases while preparing for the commercial launch of deucrictibant.

Who leads Pharvaris?

Pharvaris is led by a team with deep expertise in HAE and rare diseases, including members who were instrumental in the development and approval of icatibant.

Where can I find more information about Pharvaris?

For more information, visit Pharvaris’ website at https://pharvaris.com/.
Pharvaris N.V. Ordinary Shares

Nasdaq:PHVS

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1.00B
32.65M
9.49%
87.51%
0.25%
Biotechnology
Healthcare
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United States of America
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