Pharvaris Shares Surge 27% After Deucrictibant Phase 3 Trial Meets Primary Endpoint

Pharvaris (NASDAQ:PHVS) shares jumped 27% on Tuesday after the company reported positive topline results from its pivotal Phase 3 CHAPTER-3 study evaluating deucrictibant XR for the prevention of hereditary angioedema attacks.

The study met its primary endpoint, with once-daily deucrictibant XR producing an 83% reduction in the HAE attack rate compared with placebo.

Among participants with HAE Type 1 or Type 2, the treatment delivered an 87% reduction in attack rates versus placebo.

Pharvaris said CHAPTER-3 is the first and only Phase 3 prophylaxis study to evaluate patients across all three types of HAE.

CHAPTER-3 Meets Secondary Efficacy Endpoints

The global, double-blind, placebo-controlled trial evaluated a 40 mg once-daily oral tablet of deucrictibant XR in adolescents and adults with HAE.

A total of 85 participants from 21 countries were randomised on a 2:1 basis to receive either deucrictibant XR or placebo over a 24-week treatment period.

All secondary efficacy endpoints were also met with statistical significance, according to the company.

The treatment was generally well tolerated, with most treatment-emergent adverse events classified as mild or moderate. No treatment-related serious adverse events were reported.

One participant in the deucrictibant XR group and one in the placebo group discontinued treatment because of an adverse event.

Pharvaris Targets Regulatory Submissions in 2027

Pharvaris plans to use the CHAPTER-3 results as the basis for marketing authorisation applications, with submissions expected to begin during the first half of 2027.

The company intends to submit a New Drug Application to the U.S. Food and Drug Administration for deucrictibant XR for the prophylaxis of bradykinin-mediated angioedema attacks during the same period.

Pharvaris is separately progressing deucrictibant IR, the immediate-release formulation intended for on-demand treatment of HAE attacks, which is already undergoing regulatory review.

The Phase 3 results represent an important clinical milestone for the deucrictibant programme, although regulatory approval remains subject to review of the complete clinical and supporting data by health authorities.

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