Pharvaris Announces FDA Acceptance of New Drug Application for Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

Pharvaris Announces FDA Acceptance of New Drug Application for Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

If approved, deucrictibant will be the first oral bradykinin B2 receptor antagonist to treat HAE attacks

NDA includes positive data from successful clinical program demonstrating rapid relief and sustained response to resolution of HAE attack symptoms and a well-tolerated safety profile

PDUFA action date set for April 23, 2027

ZUG, Switzerland, July 06, 2026 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today 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 (ODT) of Hereditary Angioedema (HAE) attacks. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027.

“After 10 years of dedicated effort by the team at Pharvaris, this FDA acceptance of deucrictibant IR’s NDA represents a major milestone in our journey to develop a differentiated therapy with the potential to improve the standard of care for people living with HAE,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Pharvaris has a deep scientific legacy in bradykinin B2 receptor antagonism, a clinically proven therapeutic approach for HAE attack treatment. By leveraging this trusted mechanism and its chemical properties, deucrictibant IR has the potential to be an oral on-demand medicine that addresses unmet needs of those living with HAE. In clinical studies, treatment o...