Pharvaris stock surges 27% on positive trial data
Pharvaris (NASDAQ:PHVS) saw its stock jump 27% Tuesday after the company unveiled favorable topline data from the CHAPTER-3 pivotal Phase 3 study of deucrictibant XR, designed to prevent hereditary angioedema (HAE) attacks.
The trial met its primary endpoint, demonstrating an 83% reduction in attack rate compared with placebo. Pharvaris noted that CHAPTER-3 is the first and only Phase 3 prophylaxis study to include patients with all three types of HAE. Among those with HAE Type 1 or Type 2, the therapy cut attack rates by 87% relative to placebo.
This global Phase 3, double-blind, placebo-controlled study assessed an orally administered 40 mg once-daily tablet of deucrictibant XR for attack prevention in adolescents and adults with HAE. A total of 85 participants were enrolled across 21 countries and randomized 2:1 to receive either deucrictibant XR or placebo over a 24-week treatment period.
All secondary efficacy endpoints were achieved with statistical significance. Deucrictibant XR was generally well tolerated, with most treatment-emergent adverse events classified as mild or moderate. No treatment-related serious adverse events occurred, and one patient from each treatment arm discontinued because of an adverse event.
Pharvaris said the CHAPTER-3 results will form the basis for marketing authorization applications, with submissions planned to start in the first half of 2027.
The company also intends to file a New Drug Application with the U.S. Food and Drug Administration for prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027. In addition, Pharvaris has an ongoing FDA review of its New Drug Application for deucrictibant IR as an on-demand treatment for HAE attacks.
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