Pharvaris N.V. - PHVS STOCK NEWS

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).

Pharvaris (PHVS) presented long-term clinical data for deucrictibant in treating hereditary angioedema (HAE) at the 2025 AAAAI/WAO Joint Congress. Key findings from the CHAPTER-1 OLE study showed sustained protection from HAE attacks over 1.5 years, with the median proportion of days with symptoms reduced to zero. All participants reaching week 62 reported improved health-related quality of life.

In the RAPIDe-2 extension study, data from seven upper airway attacks showed a median time of 0.9 hours to symptom relief, consistent with results from 328 non-airway attacks. 85.7% of upper airway attacks were effectively treated with a single dose. The maximum exposure to deucrictibant was 20.8 months in the OLE study and 23.7 months overall, with no safety signals observed in both extension studies.

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference 2025. The conference will be held from March 10-12, 2025, at the W South Beach Hotel in Miami, FL.

The company, which specializes in treatments for bradykinin-mediated diseases including hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), will provide a live audio webcast of their presentation through their investor relations website. The recording will remain accessible for 30 days following the event.

Pharvaris (NASDAQ: PHVS) has outlined its strategic priorities for 2025, focusing on the clinical development of deucrictibant for hereditary angioedema (HAE) and acquired angioedema (AAE). The company has initiated CHAPTER-3, a pivotal Phase 3 study for HAE prophylaxis, with topline data expected in 2H2026. The RAPIDe-3 Phase 3 study for on-demand HAE treatment continues with topline data anticipated in 1Q2026.

The company plans to expand into AAE treatment with a clinical study planned for 2025. Pharvaris maintains a strong financial position with cash runway extending into 3Q2026. Recent corporate expansion includes key hires in Sales & Marketing and Business Development to support launch preparedness. The company will present at upcoming investor conferences and medical congresses, including AAAAI 2025, where long-term safety and efficacy data for deucrictibant will be presented.

Pharvaris reported Q3 2024 financial results and business updates. The company maintains a strong financial position with €305 million in cash. R&D expenses increased to €25.8 million from €18.5 million YoY, while G&A expenses rose to €12.1 million from €7.7 million. Net loss widened to €41.7 million (€0.77 per share) from €23.6 million (€0.58 per share) YoY.

The company plans to initiate CHAPTER-3, a Phase 3 study for deucrictibant in HAE prophylaxis by year-end 2024. Long-term extension data showed 93% reduction in attacks for prophylaxis and median symptom relief onset of ~1.1 hours for on-demand treatment.

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks, has announced its participation in the Inaugural Guggenheim Securities Healthcare Innovation Conference. The event will take place at the InterContinental Boston from November 11-13, 2024.

The company will participate in a fireside chat on Wednesday, November 13, at 9:30 a.m. ET. A live audio webcast will be available on the Investors section of the Pharvaris website, with the replay accessible for 30 days after the presentation.

Pharvaris (Nasdaq: PHVS) presented seven posters at the 2024 ACAAI Annual Scientific Meeting, showcasing data supporting deucrictibant's development for hereditary angioedema (HAE). The CHAPTER-1 Phase 2 clinical trial demonstrated deucrictibant's efficacy in reducing HAE attack symptoms to 1.7% (40 mg/day) from 14.6% (placebo). The ongoing open-label extension study showed approximately 80% of participants achieved at least a 90% reduction in attack rate. Non-clinical data from bradykinin challenge models in non-human primates supported the drug's pharmacokinetic and pharmacodynamic profile, validating the dosing strategies for both prophylactic and on-demand treatment of HAE attacks.

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company, announced the acceptance of multiple abstracts for presentation at upcoming scientific meetings. The presentations will focus on deucrictibant, an oral bradykinin B2 receptor antagonist for treating hereditary angioedema (HAE) attacks.

Key events include:

• Seven e-Poster presentations at the American College of Allergy, Asthma, & Immunology's Annual Scientific Meeting in Boston, October 24-28, 2024
• Three poster presentations at the Canadian Society of Allergy and Clinical Immunology in Banff, Alberta, November 6-9, 2024
• One oral presentation at the Japanese Society of Allergology in Kyoto, October 18-20, 2024

The presentations will cover various aspects of deucrictibant, including long-term safety and efficacy, biomarker assays, and results from clinical trials such as CHAPTER-1 and RAPIDe-2.

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks, will host a virtual investor event on October 23, 2024, at 10:00 a.m. ET/16:00 CET. The event will focus on:

• Unmet needs in prophylactic and on-demand HAE attack treatment
• Potential of deucrictibant to address these needs
• Current HAE market dynamics

Presenters include medical experts Dr. Michael E. Manning and Dr. Raffi Tachdjian, along with Pharvaris executives Berndt Modig (CEO), Dr. Peng Lu (CMO), and Dr. Wim Souverijns (CCO). A live Q&A session will follow the presentations, and an archived replay will be available for at least 30 days after the event.