With strong Phase 3 data and NDA submission imminent, PHVS is positioned for potential approval and commercialization catalysts in 2026–2027. Traders should monitor FDA feedback and upcoming CHAPTER-3 data, which could further validate the prophylactic indication and expand market potential.
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Executive Summary
Pharvaris presented positive Phase 3 RAPIDe-3 and long-term CHAPTER-1 trial data for deucrictibant, an oral B2 receptor antagonist for treating and preventing hereditary angioedema (HAE) attacks. The drug demonstrated rapid symptom relief (1.28 hours), complete resolution in 11.95 hours, and sustained efficacy with once-daily dosing, supporting its potential as a best-in-class oral therapy. No safety signals were observed over nearly three years of use.
Key Facts
- RAPIDe-3 Phase 3 trial met primary and all 11 secondary endpoints for on-demand treatment of HAE attacks with deucrictibant.
- Median time to symptom relief: 1.28 hours (vs. >12 hours placebo); complete resolution in 11.95 hours (vs. >48 hours placebo).
- CHAPTER-1 open-label extension showed sustained efficacy over ~3 years: attack rate dropped from 2.18 to 0.12 attacks/month; ~50% of patients attack-free.
- Deucrictibant was well tolerated with no treatment-related serious adverse events or discontinuations.
- Pharvaris is preparing an NDA submission for the immediate-release capsule in H1 2026; topline data from the pivotal CHAPTER-3 prophylaxis trial expected Q3 2026.
Financial Impact
Potential blockbuster drug profile with oral convenience and injectable-like efficacy could position deucrictibant as standard of care, significantly increasing valuation if approved.
Risk Factors
- Regulatory delays or rejection of NDA submission despite positive data.
- Competition from existing injectable and oral HAE therapies (e.g., Takhzyro, Kalbitor, Orladeyo).
- Failure to replicate results in ongoing CHAPTER-3 trial for prophylaxis.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3247196 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 15, 2026 17d ago | Insider Cluster | $38.06 $36.37 | ▲ +4.44% | ▲ +5.26% | $31.07 (+18.38%) |
Sep 14, 2026 17d ago | 144 | $38.06 $35.20 | ▼ −7.51% | ▼ −9.63% | $31.07 (−18.38%) |
Sep 14, 2026 18d ago | Insider Cluster | $38.86 $36.02 | ▼ −7.31% | ▼ −7.41% | $31.07 (−20.06%) |
Sep 11, 2026 21d ago | Insider Cluster | $38.02 $36.37 | ▼ −4.34% | ▼ −4.12% | $31.07 (−18.29%) |
Sep 8, 2026 24d ago | 6-K | $37.84 $38.86 | ▲ +2.70% | ▲ +3.36% | $31.07 (−17.90%) |
Aug 12, 2026 7w ago | 6-K | $36.46 $36.27 | ▼ −0.52% | ▼ −0.08% | $31.07 (−14.80%) |
Aug 12, 2026 7w ago | Press Release | $36.46 $36.27 | ▼ −0.52% | ▼ −0.08% | $31.07 (−14.80%) |
Aug 6, 2026 8w ago | Press Release | $34.45 $34.04 | ▼ −1.19% | ▼ −2.40% | $31.07 (−9.83%) |
Jul 6, 2026 12w ago | Press Release | $33.22 $35.07 | ▲ +5.57% | ▲ +5.08% | $31.07 (−6.49%) |
Jul 1, 2026 13w ago | Insider Cluster | $33.86 $35.96 | ▲ +6.20% | ▲ +5.27% | $31.07 (−8.25%) |
US Market Status
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