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 of HAE attacks with deucrictibant IR resulted in rapid time to onset of symptom relief and accelerated time to complete symptom resolution. With the build out of our commercial infrastructure already underway, Pharvaris is poised for a successful launch of deucrictibant IR, if approved.”

Pharvaris’ NDA details a comprehensive clinical development program for deucrictibant IR, including data from the treatment of over 1,300 HAE attacks. RAPIDe-3 (NCT06343779), a global, pivotal, placebo-controlled Phase 3 study of deucrictibant IR for the on-demand treatment of attacks in participants 12 years and older with HAE, including those with HAE with normal C1 inhibitor, met the primary and all 11 secondary efficacy endpoints with statistical significance. Results from RAPIDe-3 demonstrated the rapid and sustained efficacy of deucrictibant IR in treating HAE attacks; the median time to onset of symptom relief was 1.28 hours, to End of Progression™ (EoP) was 17.48 minutes, and to complete resolution of attack symptoms was 11.95 hours. Deucrictibant IR demonstrated a well-tolerated safety profile. Deucrictibant was granted orphan drug designation by the FDA in 2022.