Pharvaris Says FDA Accepts NDA For Deucrictibant IR Capsule (20 Mg) For On-Demand Treatment Of Hereditary Angioedema Attacks; PDUFA Target A
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 Heredit...
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.