Shares of Pharvaris (NASDAQ:PHVS) rose 27% on Tuesday following the release of positive topline data from the CHAPTER-3 pivotal Phase 3 trial of deucrictibant XR, an oral treatment being evaluated for the prevention of hereditary angioedema, or HAE, attacks.
The company reported that the study met its primary endpoint, demonstrating an 83% reduction in attack rate compared with placebo. In the subgroup of participants with HAE Type 1 or Type 2, the treatment produced an 87% reduction in attack rate versus placebo, according to the topline announcement.
CHAPTER-3 was conducted as a global, randomized, double-blind, placebo-controlled Phase 3 study. The trial evaluated deucrictibant XR administered orally as a 40 mg once-daily tablet for prophylaxis of HAE attacks in adolescents and adults. A total of 85 participants from 21 countries were randomized in a 2:1 ratio to receive either deucrictibant XR or placebo over a 24-week treatment period.
Pharvaris said all secondary efficacy endpoints were met with statistical significance. The company also reported that deucrictibant XR was generally well tolerated: most treatment-emergent adverse events were characterized as mild or moderate, and there were no treatment-related serious adverse events recorded. The company noted that one participant in each treatment arm discontinued therapy owing to an adverse event.
According to the company, data from CHAPTER-3 will be used to support marketing authorization applications, with filings planned to begin in the first half of 2027. Pharvaris also stated plans to submit a New Drug Application to the U.S. Food and Drug Administration in the first half of 2027 for the prophylactic indication targeting bradykinin-mediated angioedema attacks.
In parallel, Pharvaris has an ongoing regulatory review of an NDA for deucrictibant immediate-release, the formulation intended for on-demand treatment of HAE attacks. The company did not provide additional timelines beyond the planned submission window for the prophylactic XR application.
Context and market response
The CHAPTER-3 topline announcement triggered a pronounced move in Pharvaris shares as investors reacted to the trial's positive efficacy and tolerability findings. The company emphasized that CHAPTER-3 evaluated all three types of HAE in a prophylaxis Phase 3 setting, a point it highlighted in its release.
What remains to be seen
Pharvaris will proceed with regulatory filings based on the CHAPTER-3 dataset, with the company targeting the first half of 2027 to begin submissions for marketing authorization and the FDA New Drug Application for prophylactic use. The outcome of those regulatory reviews and any subsequent labeling, timing, or approval decisions were not detailed in the topline release.