Pharvaris (NASDAQ:PHVS) dominated the clinical spotlight at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 meeting on Monday, unveiling full data from its RAPIDe-3 and CHAPTER-1 trials.
The results provide a compelling case for deucrictibant as the first oral therapy capable of delivering the rapid efficacy typically reserved for injectable treatments in both on-demand and prophylactic HAE settings.
The pivotal Phase 3 RAPIDe-3 study, which evaluated a 20 mg immediate-release capsule for on-demand treatment, met its primary endpoint and all 11 secondary efficacy endpoints with high statistical significance.
Median time to onset of symptom relief was 1.28 hours for deucrictibant versus over 12 hours for placebo.
Median time to complete symptom resolution was 11.95 hours, compared to more than 48 hours for the placebo group.
The "End of Progression™"—the moment symptoms stop worsening—occurred in a median of 17.47 minutes, while 93.2% of treated attacks required no rescue medication.
Simultaneously, Pharvaris shared final data from the CHAPTER-1 Phase 2 open-label extension (OLE), reinforcing deucrictibant’s role in long-term prevention.
Over a three-year period, the mean HAE attack rate plummeted from 2.18 attacks per month at baseline to just 0.12 attacks per month.
Notably, roughly half of the participants remained entirely attack-free during the extension, and no treatment-related serious adverse events were reported.
Pharvaris enters 2026 with a robust balance sheet, reporting $356 million in cash as of late 2025.
This provides a runway into the first half of 2027, covering the next major catalyst: topline Phase 3 data from the CHAPTER-3 prophylaxis study, expected in the third quarter of 2026.
The company plans to begin filing global marketing applications for the on-demand formulation in the first half of 2026.