Pharvaris N.V. (PHVS) Form 6-K — Sep 8, 2026
Pharvaris furnished a 6-K on September 8, 2026 containing an investor presentation highlighting positive CHAPTER-3 Phase 3 topline data for deucrictibant extended-release tablets (40 mg/day) as long-term prophylaxis in hereditary angioedema. In the 24-week, 85-participant trial, deucrictibant XR achieved the primary endpoint with an 83% reduction in HAE attack rate versus placebo (95% CI: 72-90%, p<0.0001), including an 87% reduction in the HAE Type 1/2 subgroup. All key secondary endpoints were met with statistical significance, quality-of-life (AE-QoL) improved meaningfully, protection began within one week and was sustained, and there were no treatment-related serious adverse events.
Key figures
- P value
- p<0.0001
- Subgroup n
- 80
- Randomization
- 55 deucrictibant XR vs 30 placebo
- Pdufa goal date
- April 23, 2027
- Study enrollment
- 85
- Treatment duration
- 24 weeks
- Confidence interval
- 72-90%
- Ae qol ls mean change
- -32.23 vs -8.70 placebo (difference -23.53)
- Ltp us nda submission
- 1H2027
- Ae qol difference p value
- p<0.0001
- Creaate phase 3 part 1 topline
- 1Q2027
- Teae rate treatment vs placebo
- 76.4% vs 56.7%
- Hae type 1 2 subgroup reduction
- 87%
- Primary endpoint attack rate reduction
- 83%
AI analysis
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