Pharvaris Shares Soar 27% on Positive Phase 3 Data for HAE Drug

Shares of Pharvaris (NASDAQ:PHVS) surged 27% on Tuesday after the company reported positive topline data from a pivotal Phase 3 study of its drug candidate, deucrictibant XR. The trial evaluated the oral medication for the prevention of hereditary angioedema (HAE) attacks, a rare genetic disorder.

Pivotal Trial Meets Primary Endpoint

The CHAPTER-3 study successfully met its primary endpoint, demonstrating a statistically significant 83% reduction in the rate of HAE attacks compared to a placebo, Pharvaris announced. The company noted that for participants with HAE Type 1 or Type 2, the attack rate reduction was even greater at 87%.

The global, double-blind, placebo-controlled study enrolled 85 adult and adolescent participants across 21 countries. Patients were administered a 40 mg once-daily dose of the deucrictibant XR tablet or a placebo over a 24-week period. The company also confirmed that all secondary efficacy endpoints were met with statistical significance.

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Safety Profile and Regulatory Path

According to the company's release, the treatment was well tolerated. Most treatment-emergent adverse events were reported as mild or moderate, and there were no treatment-related serious adverse events. One participant from both the treatment and placebo groups discontinued the study due to an adverse event.

Pharvaris stated that the positive data will form the basis for marketing authorization applications. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for the prophylaxis of HAE attacks in the first half of 2027. This follows an ongoing regulatory review for an on-demand version of the drug, deucrictibant IR, for treating active HAE attacks.