Pharvaris, a late-stage biopharmaceutical company developing oral treatments for bradykinin-mediated angioedema, reported second quarter 2026 financial results. The company held €318 million in cash and cash equivalents as of 30 June 2026. The FDA is reviewing Pharvaris' New Drug Application for deucrictibant IR, with a PDUFA date of 23 April 2027. The EMA validated the marketing authorisation application in July 2026. Pharvaris expects topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for hereditary angioedema prophylaxis, in the third quarter of 2026. Enrolment continues in CREAATE, a pivotal study for acquired angioedema treatment. The company closed a $132 million underwritten offering in May, extending its cash runway into 2028. Second quarter loss was €47.8 million, with R&D expenses of €35.0 million and G&A expenses of €15.8 million.

Pharvaris NV - FDA sets PDUFA action date for Deucrictibant IR NDA as April 23, 2027. Monday, Jul 6, 2026 6:50 am ET 1min read The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2027, for the New Drug Application (NDA) of deucrictibant immediate-release (IR) for the on-demand treatment of hereditary angioedema (HAE) attacks. This date marks the target by which the FDA aims to complete its review of the application, which is expected to be submitted in the first half of 2026. Pharvaris, a late-stage biopharmaceutical company, has been preparing the NDA dossier based on data from the RAPIDe-3 and RAPIDe-2 trials. The RAPIDe-3 study, a pivotal global Phase 3 trial, demonstrated that deucrictibant IR met its primary endpoint, with median time to onset of symptom relief of 1.28 hours, significantly faster than placebo. The company also plans to present additional data from these trials at upcoming medical congresses. The NDA filing is part of Pharvaris' broader strategy to commercialize deucrictibant for both on-demand and prophylactic treatment of HAE attacks. The company remains on track to submit the NDA in 1H2026, with clear timeline for regulatory review provided by the PDUFA date. Pharvaris also continues to advance its clinical development programs, including the ongoing CREAATE study for AAE-C1INH and the CHAPTER-3 trial for long-term prophylaxis of HAE attacks, with topline data expected in the third quarter of 2026. The company's cash runway extends into the first half of 2027, supporting its current development and commercialization efforts. The FDA's action date reflects the agency's prioritization of the application and provides a key milestone for Pharvaris as it moves toward potential regulatory approval and market launch of deucrictibant IR for HAE.