Initiated CHAPTER-3, the pivotal Phase 3 study of deucrictibant for prophylaxis against hereditary angioedema (HAE) attacks in 2024; topline data anticipated in 2H2026Enrollment in RAPIDe-3, the pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, continuing as planned; topline data anticipated in 1Q2026Study initiation of deucrictibant for the treatment of acquired angioedema due to C1-INH deficiency (AAE-C1INH) anticipated in 2025Operating from a strong financial position wit ...

Core Insights - Pharvaris is advancing the clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist, for the prevention and treatment of hereditary angioedema (HAE) attacks [1][9] - The company plans to initiate the pivotal Phase 3 study, CHAPTER-3, for prophylactic treatment of HAE by the end of 2024 [1][3] - Recent presentations at medical congresses highlighted positive long-term extension data for deucrictibant, reinforcing its differentiated profile and potential efficacy [2][3] Clinical Development Updates - CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study aimed at enrolling approximately 81 participants aged 12 years and older, with a primary endpoint focused on the efficacy of deucrictibant compared to placebo [3] - Enrollment in the RAPIDe-3 study, a global pivotal Phase 3 study for on-demand treatment of HAE, is progressing as planned with a target of approximately 120 participants [3] - Long-term prophylaxis data from the CHAPTER-1 OLE study showed a 93% reduction in attacks compared to baseline, while the RAPIDe-2 OLE study indicated a median onset of symptom relief in approximately 1.1 hours [3][4] Financial Position - As of September 30, 2024, the company reported cash and cash equivalents of €305 million, down from €391 million at the end of 2023 [6] - Research and Development expenses for Q3 2024 were €25.8 million, an increase from €18.5 million in Q3 2023, while General and Administrative expenses rose to €12.1 million from €7.7 million in the same period [6] - The company reported a loss of €41.7 million for Q3 2024, with a basic and diluted loss per share of €0.77, compared to a loss of €23.6 million and a loss per share of €0.58 in Q3 2023 [6] Future Plans - The company intends to expand the clinical development of deucrictibant into acquired angioedema due to C1-INH deficiency (AAE-C1INH) following promising data from an investigator-initiated trial [4] - Upcoming investor events include participation in the Evercore ISI's 7th Annual HealthCONx Conference and the Oppenheimer Movers in Rare Disease Summit [5]

Core Insights - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for the prevention and treatment of hereditary angioedema (HAE) attacks [2] Group 1: Company Overview - Pharvaris aims to provide effective, well-tolerated, and easy-to-administer treatment alternatives for HAE patients, both on-demand and prophylactically [2] - The company is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate another pivotal Phase 3 study for prevention by the end of 2024 [2] Group 2: Upcoming Events - Pharvaris management will participate in the Inaugural Guggenheim Securities Healthcare Innovation Conference from November 11-13, 2024, with a fireside chat scheduled for November 13 at 9:30 a.m. ET [1] - A live audio webcast of the event will be available on the Investors section of the Pharvaris website, with a replay accessible for 30 days post-presentation [1]

Core Insights - Pharvaris is hosting a virtual investor event on October 23, 2024, to discuss the unmet needs in hereditary angioedema (HAE) treatment and the potential of its drug, deucrictibant [1] - The event will feature presentations from key medical and executive personnel, followed by a live Q&A session [2] - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for HAE, with ongoing Phase 3 studies for both on-demand and prophylactic treatments [3] Company Overview - Pharvaris is developing novel, oral bradykinin B2 receptor antagonists aimed at preventing and treating HAE attacks [3] - The company aims to provide effective and well-tolerated treatment alternatives for bradykinin-mediated angioedema [3] - Positive data from Phase 2 studies has encouraged Pharvaris to advance deucrictibant, with pivotal Phase 3 studies currently enrolling [3]

Core Insights - Pharvaris is set to initiate the pivotal Phase 3 clinical study, CHAPTER-3, for deucrictibant, aimed at the prophylactic treatment of hereditary angioedema (HAE) by the end of 2024 [1][2] - The company plans to expand the clinical development of deucrictibant to include acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH) as a new indication [1][3] - The CEO of Pharvaris expressed confidence in deucrictibant's potential to become a preferred therapy for HAE management, supported by new long-term extension study data [2] Clinical Development - CHAPTER-3 will evaluate the efficacy and safety of once-daily dosing of deucrictibant extended-release tablets, designed to maintain therapeutic plasma levels for over 24 hours [2][3] - The study is on track to begin by the end of 2024, with startup activities progressing as planned [2] - Data from ongoing studies indicate that deucrictibant can provide injectable-like efficacy with favorable tolerability and convenience of oral administration [3] Research Findings - A recent investigator-initiated trial at Amsterdam UMC demonstrated that deucrictibant significantly reduced mean monthly attack rates in patients with AAE-C1INH, with no severe adverse events reported [3][4] - The results from this trial support the hypothesis that deucrictibant can effectively prevent and treat AAE-C1INH, addressing an unmet medical need [4] Upcoming Events - Pharvaris will present findings at the CIIC Fall 2024 Conference, including long-term efficacy and safety data from the RAPIDe-2 and CHAPTER-1 extension studies [6] - A live conference call will be held to discuss updates and data in detail, with presentation materials available on the company's investor relations website [7] Product Overview - Deucrictibant is a novel oral bradykinin B2 receptor antagonist, developed in both extended-release and immediate-release formulations for prophylactic and on-demand treatment of HAE [8][9] - The company aims to provide effective, well-tolerated, and easy-to-administer alternatives for patients with bradykinin-mediated angioedema [9]

ZUG, Switzerland, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced a summary of data being presented at the ongoing 7th Bradykinin Symposium. Details of the presentations are outlined below: Long-Term Safety and Efficacy of Oral Deucrictibant for HAE Prophylaxis, a poster presentation by Marc A. Riedl, M.D., M.S. In the current ...

ZUG, Switzerland, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced the acceptance of two abstracts for oral presentation and ten abstracts for poster presentation at the upcoming 7th Bradykinin Symposium, to be held from September 5-6, 2024, in Berlin, Germany. Presentation details are as follows: Title: Bradykinin Challenge Mod ...

Alignment with regulatory agencies following End-of-Phase 2 meetings for the prophylactic development of deucrictibant; global startup activities of CHAPTER-3, pivotal Phase 3 study of deucrictibant for the prevention of hereditary angioedema (HAE) attacks, underway Enrollment of RAPIDe-3, a global pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, progressing as planned Executing from a strong financial position with cash and cash equivalents of €344 million as of June 30, 2 ...

ZUG, Switzerland, June 11, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the annual general meeting of shareholders will take place on Friday, June 28, 2024, at 15:00 CEST (9:00 a.m. EDT). About Pharvaris All relevant documents and information relating to the annual general meeting, including the notice and agenda for the annual gener ...

About Pharvaris All relevant documents and information relating to the annual general meeting, including the notice and agenda for the annual general meeting, are or will be made available in the "Investors" section of Pharvaris' website under "Events & Presentations". The documents will also be made available on the SEC's website at www.sec.gov. Shareholders who wish to attend the meeting should register as described in the notice and agenda for the annual general meeting. ZUG, Switzerland, June 11, 2024 ( ...