Pharvaris N.V.

Pharvaris N.V. reported a net loss of €47.8 million for the second quarter of 2026, with cash and cash equivalents of €318 million as of June 30, 2026. The company anticipates topline data from its pivotal Phase 3 CHAPTER-3 study in 3Q2026 and noted that its deucrictibant IR NDA is under FDA review with a PDUFA date of April 23, 2027. Additionally, the EMA validated the MAA for deucrictibant IR, and a $132 million offering extended the cash runway into 2028.

Pharvaris announced its Q2 2026 financial results and business updates, highlighting significant progress in its deucrictibant development program. The FDA accepted the New Drug Application for deucrictibant IR with a PDUFA date of April 23, 2027, and the EMA validated its Marketing Authorization Application. The company also expects topline data from its pivotal CHAPTER-3 Phase 3 study in 3Q2026 and reported a strong cash position of €318 million.

Pharvaris N.V. announced the publication of results from the first in-depth qualitative study assessing the experiences of people with acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH). The study, published in Frontiers in Immunology, provides foundational insights into the disease burden and validates patient-reported outcome measures. These findings directly informed the design and endpoint selection for the company's ongoing Phase 3 CREAATE study, which is investigating deucrictibant for the prophylaxis and on-demand treatment of AAE-C1INH attacks, an ultra-rare condition with no approved therapies.

Pharvaris announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027. If approved, deucrictibant will be the first oral bradykinin B2 receptor antagonist to treat HAE attacks, with the NDA including positive data from a successful clinical program demonstrating rapid relief and sustained response.

Pharvaris N.V. shareholders approved several key items at a recent meeting. These included the adoption of the Dutch statutory annual accounts for 2025 and the appointment of PricewaterhouseCoopers Accountants N.V. as the external auditor for 2026. Shareholders also discharged directors from liability for their 2025 duties, extended the authorization for the Board to acquire shares, and re-appointed Dr. Margareta Elisabeth Björk as a non-executive director.

Pharvaris presented positive data from its deucrictibant clinical program at the EAACI Annual Congress 2026. The Phase 3 RAPIDe-3 study for on-demand treatment of HAE attacks demonstrated rapid and sustained efficacy, with a median time to symptom relief of 1.28 hours and a median time to End of Progression (EoP) of 17.47 minutes. Additionally, long-term data from the CHAPTER-1 open-label extension study showed sustained efficacy, reducing HAE attack rates by approximately 92%, and a favorable cardiovascular safety profile across all studies.

Pharvaris N.V. announced its Annual General Meeting of shareholders will be held on Friday, June 26, 2026, at 4:00 p.m. CEST in Amsterdam. The agenda includes the adoption of the 2025 annual accounts, the appointment of PricewaterhouseCoopers Accountants N.V. as the external independent auditor for 2026, and the re-appointment of Dr. Margareta Elisabeth Björk as a non-executive director. Shareholders will also vote on the discharge of directors from liability for 2025 and the extension of authorization for the Board to acquire shares. Relevant documents are available on the company's website and the SEC's website.

Pharvaris N.V. announced that its Annual General Meeting of shareholders will take place on Friday, June 26, 2026, at 16:00 CEST. All relevant documents and information for the meeting are or will be made available in the "Investors" section of the company's website and on the SEC's website. Pharvaris is a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists for conditions like hereditary angioedema, with topline data for its CHAPTER-3 Phase 3 study anticipated in Q3 2026.

Pharvaris announced the acceptance of eight abstracts for presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2026. This includes one oral presentation and seven flash talk/poster presentations, highlighting significant progress in its clinical programs. The presentations will detail results from the Phase 3 RAPIDe-3 trial for on-demand treatment of hereditary angioedema (HAE) attacks, clinical cardiovascular safety assessments, and long-term safety and efficacy data from the Phase 2 CHAPTER-1 open-label extension study for HAE prophylaxis. The company continues to advance its oral bradykinin B2 receptor antagonists for bradykinin-mediated diseases.

Pharvaris reported a net loss of €39.2 million for the first quarter ended March 31, 2026, an improvement from the €46.3 million loss in the prior year period. The company maintained €247 million in cash and cash equivalents as of quarter-end, with a subsequent $132 million underwritten offering extending its cash runway into 2028. Key business updates include anticipated topline data from the CHAPTER-3 Phase 3 study in 3Q2026 and the New Drug Application submission for deucrictibant IR on-track for 1H2026.