Tuesday brought some very good news for patients with hereditary angioedema and for investors who bet on the biotech trying to help them. Pharvaris NV (NASDAQ: PHVS) saw its stock surge more than 17% after the company reported positive topline results from its late-stage clinical trial of an oral drug designed to prevent the painful swelling attacks that define the condition.
The drug, deucrictibant extended-release (XR), is a daily tablet that aims to stop HAE attacks before they start. And according to the data, it works remarkably well.
Rapid Onset And Sustained Protection
The global, double-blind CHAPTER-3 trial tested a 40 mg daily dose of deucrictibant XR against a placebo over 24 weeks. The study enrolled 85 participants, and it stands out as the only Phase 3 prophylaxis study to include patients with all three types of HAE: type 1, type 2, and HAE with normal C1 inhibitor.
For the entire group, patients taking the daily pill experienced an 83% reduction in their mean monthly attack rate compared to the placebo group. But the numbers get even better when you look at the 80 participants specifically diagnosed with HAE Type 1 or Type 2: their monthly attack rate dropped by 87%.
What's particularly striking is how quickly the protection kicked in. Participants achieved meaningful defense within the first week of treatment, and that benefit held steady throughout the entire 24-week study. The result was a robust increase in the number of patients who remained attack-free for the duration of the trial.
Favorable Safety Profile And Next Steps
Safety data looked clean, which is always a relief in drug development. Participants tolerated the treatment well, with mostly mild to moderate adverse events reported and no treatment-related serious adverse events. Only one patient in each study arm discontinued the trial due to an adverse event, which suggests the drug's side effect profile is manageable.
With these results in hand, Pharvaris is moving quickly toward regulatory submission. The company plans to file a New Drug Application with the U.S. Food and Drug Administration in early 2027. Meanwhile, the CHAPTER-4 open-label extension study continues to monitor long-term effects, and the company expects topline data from a separate Phase 3 trial for acquired angioedema in the first quarter of 2027.
PHVS Stock Price Activity: Pharvaris shares were up 17.02% to $41.25 at the time of publication on Tuesday, according to market data.
