Pharvaris' CHAPTER-3 Hits Primary Endpoint: 83% Attack Reduction in HAE Prophylaxis
PHVS sits 94% 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. The primary endpoint and all secondary efficacy endpoints were met with statistical significance. Treatment reduced mean monthly attack rate by 83% (p<0.0001) across all HAE types, and by 87% in the HAE Type 1/2 subgroup. Protection was early-onset within the first week and sustained through 24 weeks. Deucrictibant XR was well tolerated with no treatment-related serious adverse events. This is the first and only prophylaxis Phase 3 study to evaluate all three types of HAE. The company plans to submit an NDA for prophylaxis in H1 2027, with CREAATE Part 1 topline data for AAE-C1INH expected in Q1 2027. This follows the FDA's acceptance of the NDA for deucrictibant IR (on-demand) in July 2026, positioning Pharvaris for two potential launches. The stock is trading near its 52-week high, reflecting high expectations that these results now validate.
At the time of this announcement, PHVS was trading at $40.00 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 news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.