Monitor FDA review milestones and any advisory committee meetings ahead of the April 2027 PDUFA date. The stock may re-rate on positive review updates or if competitor developments (e.g., Takeda's TAK-994) emerge. Near-term, the acceptance removes a key binary risk but approval remains the primary catalyst.
Price Chart
Executive Summary
Pharvaris announced FDA acceptance of its New Drug Application (NDA) for deucrictibant immediate-release capsules for on-demand treatment of hereditary angioedema (HAE) attacks, with a PDUFA target action date of April 23, 2027. The NDA includes positive Phase 3 data (RAPIDe-3) showing rapid symptom relief and a well-tolerated safety profile. This milestone reduces regulatory uncertainty and positions deucrictibant as a potential first oral therapy for acute HAE attacks, though approval is still pending.
Key Facts
- FDA accepted NDA for deucrictibant IR (20 mg) for on-demand treatment of HAE attacks
- PDUFA target action date set for April 23, 2027
- Phase 3 RAPIDe-3 study met primary and all 11 secondary endpoints with statistical significance
- Median time to onset of symptom relief: 1.28 hours; median time to complete resolution: 11.95 hours
- Deucrictibant granted orphan drug designation by FDA in 2022
Financial Impact
Not directly quantified; potential for significant revenue if approved as first oral on-demand HAE therapy, but commercial launch is contingent on FDA approval and market adoption
Risk Factors
- FDA may issue a Complete Response Letter (CRL) citing safety, efficacy, or manufacturing concerns
- Competition from existing injectable therapies (e.g., icatibant, ecallantide) and potential oral entrants
- Commercial execution risk if approved, given need to build sales infrastructure
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3322293 |
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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%) |
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