The RAPIDe-3 data significantly de-risks the on-demand NDA filing expected in H1 2026. The CHAPTER-3 prophylaxis readout in Q3 2026 is the next major catalyst. Traders should monitor for FDA acceptance of the NDA and any advisory committee meeting dates. The strong efficacy and safety profile positions deucrictibant as a potential oral alternative to injectable standard-of-care, which could capture meaningful market share in the ~$4B+ HAE market.
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Executive Summary
Pharvaris presented positive Phase 3 RAPIDe-3 data at EAACI 2026, showing deucrictibant achieved a median time to onset of symptom relief of 1.28 hours vs >12 hours for placebo, and median time to complete resolution of 11.95 hours vs >48 hours. The majority of attacks (83.0%) were treated with a single capsule, and 93.2% required no rescue medication. Long-term prophylaxis data from CHAPTER-1 OLE showed ~92% reduction in attack rates and 100% of participants reporting well-controlled disease. The company is preparing NDA submission for on-demand treatment and expects topline data from the pivotal CHAPTER-3 prophylaxis study in Q3 2026.
Key Facts
- RAPIDe-3 Phase 3: median time to onset of symptom relief 1.28 hours (deucrictibant) vs >12 hours (placebo)
- Median time to complete resolution: 11.95 hours (deucrictibant) vs >48 hours (placebo)
- 83.0% of attacks treated with a single capsule; 93.2% required no rescue medication
- CHAPTER-1 OLE: ~92% reduction in HAE attack rates; ~50% of participants attack-free during entire extension
- 100% of participants reported well-controlled disease during long-term prophylaxis (Week 62 to end of study)
- Integrated CV safety analysis (~570 participants): no QT prolongation, no serious arrhythmias, no sudden cardiac death
- NDA submission for on-demand deucrictibant planned for first half of 2026; CHAPTER-3 topline data expected Q3 2026
- Deucrictibant has orphan drug designation from FDA, European Commission, and Swissmedic
Financial Impact
No financial figures provided; clinical-stage company with no approved products or revenue. Positive Phase 3 data supports regulatory filing and potential market entry in HAE (multi-billion dollar market).
Risk Factors
- Regulatory risk: FDA may require additional data or issue a Complete Response Letter despite positive Phase 3 results
- Competition: Takeda's Takhzyro (injectable), BioCryst's Orladeyo (oral prophylactic), and Ionis/Arrowhead's pipeline candidates
- Commercialization risk: Pharvaris has no commercial infrastructure; may need partnership or significant investment
- Manufacturing and supply chain risk for oral formulations
- Clinical risk: CHAPTER-3 prophylaxis study results not yet available; could differ from Phase 2 OLE data
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3311646 |
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Sep 15, 2026 17d ago | Insider Cluster | $38.06 $36.37 | ▲ +4.44% | ▲ +5.26% | $31.07 (+18.38%) |
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Jul 1, 2026 13w ago | Insider Cluster | $33.86 $35.96 | ▲ +6.20% | ▲ +5.27% | $31.07 (−8.25%) |
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