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Pharvaris N.V. reports developments as a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists for bradykinin-mediated diseases, including hereditary angioedema and acquired angioedema due to C1 inhibitor deficiency. Its lead program, deucrictibant, is being developed in immediate-release capsule and extended-release tablet forms for on-demand and prophylactic treatment settings.
Recurring updates include clinical data from the RAPIDe and CHAPTER study programs, patient-reported outcome research, scientific publications, presentations at allergy and immunology meetings, financial results, strategic priorities, shareholder voting matters and capital-structure disclosures.
Pharvaris (Nasdaq: PHVS) announced key updates for its lead compound deucrictibant in hereditary angioedema (HAE) and acquired angioedema (AAE-C1INH) treatment:
1. CHAPTER-3, a global Phase 3 study of deucrictibant extended-release tablets for HAE prophylaxis, is set to begin by year-end 2024.
2. The company plans to expand clinical development into AAE-C1INH following promising investigator-initiated trial results.
3. Long-term extension data from ongoing studies (CHAPTER-1 part 2 and RAPIDe-2) demonstrate sustained efficacy and tolerability in both prophylactic and on-demand HAE treatment.
4. Pharvaris will present additional clinical, real-world, and nonclinical data at the 2024 Bradykinin Symposium, highlighting deucrictibant's differentiated profile.
Pharvaris (Nasdaq: PHVS) presented long-term extension data for deucrictibant in the treatment of hereditary angioedema (HAE) at the Bradykinin Symposium 2024. Key findings include:
1. Prophylactic treatment: 93% reduction in attack rate compared to baseline, with a median attack rate of zero per month and 99% attack-free days after over a year of treatment.
2. On-demand treatment: Median onset of symptom relief in 1.1 hours, with 85.8% of attacks resolving completely within 24 hours.
3. Safety profile: Deucrictibant was well-tolerated with no new safety signals observed in both prophylactic and on-demand settings.
These results support deucrictibant's potential as a preferred therapy for HAE management, demonstrating efficacy in both prophylactic and on-demand treatments.
Pharvaris (Nasdaq: PHVS) presented data at the 7th Bradykinin Symposium, showcasing the potential of deucrictibant for treating hereditary angioedema (HAE). Key findings include:
1. Long-term safety and efficacy of deucrictibant for HAE prophylaxis, with a median attack rate of zero for over a year.
2. Rapid onset of symptom relief (median 1.1 hours) in treating HAE attacks.
3. Improvements in disease control and quality of life for HAE patients.
4. Favorable comparison to standard of care in a propensity score-matched analysis.
5. No evident effects on cardiac parameters in nonclinical and clinical studies.
6. Development of new biomarker assays for bradykinin-mediated disorders.
These results support the further development of deucrictibant as a potential oral therapy for HAE prevention and treatment.
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.
Summary not available.