Pharvaris' CHAPTER-3 Pivotal Study Meets Primary Endpoint: 83% Attack Rate Reduction
PHVS sits 88% above its 52-week low of $20.65.
Summary
Pharvaris announced positive topline data from its CHAPTER-3 pivotal Phase 3 study of deucrictibant XR for prophylaxis of HAE attacks, meeting the primary endpoint with an 83% attack rate reduction versus placebo.
Key Events · Product Development and Regulatory · PHVS
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CHAPTER-3 Primary Endpoint Met
Deucrictibant XR reduced mean monthly attack rate by 83% versus placebo (p<0.0001) in all HAE types; 87% reduction in HAE Type 1/2 subgroup.
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All Secondary Endpoints Met
All secondary efficacy endpoints met with statistical significance under multiplicity control; early-onset protection within first week sustained through 24 weeks.
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Regulatory Path Forward
Pharvaris plans to submit an NDA for prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027.
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Safety Profile
Deucrictibant XR was well tolerated; no treatment-related serious adverse events; one discontinuation per group due to adverse event.
Analysis · PHVS · Life Sciences
Positive topline data from the CHAPTER-3 pivotal Phase 3 study of deucrictibant XR for prophylaxis of HAE attacks were announced by Pharvaris. The primary endpoint was met with an 83% attack rate reduction versus placebo (p<0.0001), and all secondary efficacy endpoints were met with statistical significance. This is the first and only prophylaxis Phase 3 study to evaluate all three types of HAE. The data will serve as the basis for marketing authorization applications planned for submission starting in the first half of 2027. This is a landmark moment for the company, positioning deucrictibant as potentially the first and only oral therapy to offer injectable-like efficacy in both on-demand treatment and prophylaxis. The stock is trading near its 52-week high, reflecting market anticipation of this data readout.
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At the time of this filing, PHVS was trading at $38.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.5B. The 52-week trading range was $20.65 to $38.13. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.