Pharvaris N.V. Stock Price, News & Analysis

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company, will present multiple clinical trial results for deucrictibant, their oral bradykinin B2 receptor antagonist for treating hereditary angioedema (HAE), at the upcoming 2025 US HAEA National Summit in Baltimore.

The presentations include six poster sessions scheduled for July 11, covering long-term safety and efficacy data from the CHAPTER-1 and RAPIDe-2 extension studies, quality of life improvements, CHAPTER-3 Phase 3 trial design, durability of response, and comparison with standard of care. All posters will be available on the company's investor relations website.

Pharvaris presented comprehensive data at EAACI Congress 2025 showcasing the potential of deucrictibant, their oral bradykinin B2 receptor antagonist, for treating and preventing bradykinin-mediated angioedema attacks. Key findings from multiple studies demonstrated deucrictibant's efficacy: The CHAPTER-1 open-label extension study showed sustained attack reduction and improved quality of life, while the RAPIDe-2 extension study revealed a median time to symptom relief of 1.1 hours, with 97.8% of attacks achieving relief by 12 hours. Notably, 89.2% of attacks were resolved with a single dose. For upper airway attacks, 92.9% were effectively treated with one dose. The company also presented data on their novel kinin biomarker assay for better diagnosis of bradykinin-mediated conditions and insights from their AAE-C1INH research, where no approved therapies currently exist.

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for bradykinin-mediated diseases like hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), has scheduled its annual general meeting of shareholders. The meeting will take place on June 27, 2025, at 16:00 CEST (10:00 a.m. EDT). Shareholders can access all relevant meeting documents and information in the "Investors" section of Pharvaris' website under "Events & Presentations" and on the SEC's website. Interested shareholders must register to attend as outlined in the meeting notice and agenda.

Pharvaris (PHVS) presented promising data for deucrictibant in treating bradykinin-mediated angioedema at the 14th C1-Inhibitor Deficiency Workshop. The drug showed strong efficacy in both prophylactic and on-demand treatment settings. In prophylaxis, long-term data revealed sustained attack rate reduction for over 18 months, with maintained quality of life improvements. The new extended-release (XR) formulation demonstrated 24-hour therapeutic coverage supporting once-daily dosing. For on-demand treatment, 95-100% of attacks showed durable response without symptom reoccurrence after a single dose, with median symptom relief onset of 1.1 hours. Notably, deucrictibant effectively treated upper airway attacks with 92.9% requiring only one dose. The company also validated a novel biomarker assay for bradykinin-mediated angioedema, potentially expanding treatment opportunities.

Pharvaris (PHVS) has announced multiple presentations of clinical data for deucrictibant at three major medical conferences in May-June 2025. The presentations will take place at the 14th C1-Inhibitor Deficiency and Angioedema Workshop in Budapest, the 2025 Eastern Allergy Conference in Palm Beach, and the EAACI Congress 2025 in Glasgow. Key presentations focus on deucrictibant's long-term safety and efficacy data from the CHAPTER-1 and RAPIDe-2 extension studies for both prophylaxis and treatment of hereditary angioedema (HAE) attacks. Notable topics include biomarker data, quality of life improvements, pharmacokinetics of the XR tablet formulation, and the CHAPTER-3 Phase 3 trial design. The company will make all presentation materials available on their investor relations website.

Pharvaris (PHVS) reported Q1 2025 financial results and provided updates on its development pipeline. The company is advancing deucrictibant, an oral bradykinin B2 receptor antagonist, through two pivotal Phase 3 studies: CHAPTER-3 for HAE attack prophylaxis and RAPIDe-3 for on-demand treatment. The FDA granted TQT study waivers for both deucrictibant formulations. Financial highlights include: cash position of €236M (down from €281M in Q4 2024), R&D expenses of €30.9M (up from €18.5M YoY), and a net loss of €46.3M (€0.85 per share). The company expects topline data from CHAPTER-3 in 2H2026 and will host an R&D call on June 4 to discuss expansion plans beyond HAE type 1/2.

Pharvaris (PHVS) has announced a virtual R&D call scheduled for June 4, 2025, at 8:00 a.m. ET/14:00 CET, titled "Deucrictibant: Beyond HAE Type 1/2". The event will focus on exploring the potential applications of deucrictibant, their oral bradykinin B2 receptor antagonist, beyond hereditary angioedema (HAE) Type 1/2.

The presentation will cover bradykinin-mediated angioedema's pathophysiology and prevalence, current treatment landscape, unmet needs, and Pharvaris' biomarker approach for disease identification. Key speakers include medical experts from Amsterdam UMC and Pharvaris' leadership team, including their CEO, CMO, and Chief Early Development Officer.

Pharvaris (PHVS) has achieved target enrollment in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for HAE attack treatment, while enrollment continues in CHAPTER-3 for HAE attack prophylaxis with topline data expected in 2H2026.

The company received European orphan medicinal product designation for deucrictibant in bradykinin-mediated angioedema treatment. Recent clinical data presentations showed promising results in long-term prophylaxis and rapid treatment of HAE attacks, including upper-airway attacks.

Financial highlights for FY2024:

• Cash position: €281 million (down from €391 million in 2023)
• R&D expenses: €98.6 million (up from €65.6 million in 2023)
• G&A expenses: €47.1 million (up from €31.3 million in 2023)
• Net loss: €134 million or €2.48 per share (compared to €100.9 million or €2.63 per share in 2023)

Pharvaris (Nasdaq: PHVS) announced that the European Commission (EC) has granted orphan designation to its investigational drug deucrictibant for treating bradykinin-mediated angioedema. This follows the U.S. FDA's orphan drug designation granted in March 2022.

The company is currently executing a phase 3 development program to evaluate deucrictibant's efficacy and safety in hereditary angioedema (HAE). As a bradykinin B2 receptor antagonist, deucrictibant aims to block bradykinin effects, potentially offering a broader-acting treatment option for bradykinin-mediated angioedema conditions beyond HAE. The company is also in discussions with regulators regarding a pivotal trial for acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH).