Announcement • Jul 06
Pharvaris Announces FDA Acceptance of New Drug Application for Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks Pharvaris 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. 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. Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic. PHVS
Live News • Jul 06
FDA Accepts Pharvaris Deucrictibant IR NDA for Hereditary Angioedema Decision in 2027 Pharvaris reported that the FDA has accepted its New Drug Application for deucrictibant immediate-release capsules for the on-demand treatment of Hereditary Angioedema attacks, with a PDUFA target action date set for April 23, 2027.
The filing is backed by clinical data showing rapid relief, sustained response and a well-tolerated safety profile. This marks a key step toward potential commercial use of deucrictibant IR in the U.S. if the application is ultimately approved.
Pharvaris shares trade at US$33.86, with the stock up 27.9% year to date, reflecting recent momentum ahead of this long regulatory review timeline.
The long lead time to the April 2027 PDUFA date means regulatory risk remains in focus and any future FDA feedback could affect sentiment toward Pharvaris. The key question for investors is how much of this potential HAE opportunity is already reflected in the current share price. Recent Insider Transactions Derivative • Jul 01
President exercised options and sold US$942k worth of stock On the 26th of June, Peng Lu exercised 30k options at a strike price of around US$2.59 and sold these shares for an average price of US$34.30 per share. This trade did not impact their existing holding. Peng currently holds less than 1% of total shares outstanding. Company insiders have collectively sold US$2.9m more than they bought, via options and on-market transactions in the last 12 months. 
