Business
Pharvaris Reports Second Quarter 2022 Financial Results and Provides Business Update
Formal letters received from FDA relating to the previously announced hold on clinical studies of PHA121 in the U.S.Top-line data anticipated in 4Q22 for
About this update from Pharvaris N.v.
[{"type":"text","content":"Formal letters received from FDA relating to the previously announced hold on clinical studies of PHA121 in the U.S.Top-line data anticipated in 4Q22 for RAPIDe-1, a global Phase 2 study of PHVS416 for the acute treatment of HAE attacks ongoing outside the U.S.Executing from a strong financial position with cash and cash equivalents of €201 million as of June 30, 2022 ZUG, Switzerland, Sept. 12, 2022 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial results for the second quarter ended June 30, 2022, and provided a business update. “Pharvaris is dedicated to bringing therapeutic alternatives to people living with HAE and we maintain our belief in the potential of PHA121. Our team is committed to working with the FDA to resolve the hold on clinical trials involving PHA121 in the U.S. and we deeply appreciate the patience of the HAE community during this time,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Having evaluated the impact of the clinical hold, we anticipate announcing top-line Phase 2 data for RAPIDe-1 in the fourth quarter of this year. As we work to address the FDA’s concerns and continue interactions with other regulatory authorities, we maintain a disciplined operational approach with our strong cash position expected to provide runway through the first quarter of 2024.” Recent Business Updates Pharvaris announced that it has received formal clinical hold letters from the U.S. Food and Drug Administration (FDA). This follows the previously announced verbal notification of a hold on the clinical trials of PHA121 in the U.S. under Investigational New Drug (IND) applications for the on-demand and prophylactic treatment of HAE attacks. The FDA requested that Pharvaris conduct an additional long-term rodent toxicology study and update the Investigator’s Brochure. The letters stated that the nonclinical observations are unlikely due to B2 receptor antagonism. Pharvaris plans to request a Type A meeting to discuss on-demand and prophylactic proposals to address the clinical holds.RAPIDe-1, a global Phase 2 study of PHVS416 for the on-demand treatment of HAE, continues evaluating enrolled patients outside the U.S. with top-line data anticipated in 4Q22...