Pharvaris (NASDAQ: PHVS) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application for deucrictibant immediate-release capsules (20 mg), intended for the on-demand treatment of Hereditary Angioedema (HAE) attacks.
The FDA has set a target action date under the Prescription Drug User Fee Act for April 23, 2027. If approved, deucrictibant would become the first oral bradykinin B2 receptor antagonist available for treating HAE attacks.
The application is supported by positive data from a successful clinical program, which demonstrated rapid relief and sustained response in resolving HAE attack symptoms, alongside a well-tolerated safety profile.
This development marks a significant milestone for Pharvaris, which has been working for a decade to bring this differentiated therapy to market.
Berndt Modig, Chief Executive Officer of Pharvaris, stated, “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.”
