- Trial Phase
- Filed/PDUFA (IR capsule); Phase 3 (XR tablet)
- Time to Market
- IR capsule could be approved by April 23, 2027 PDUFA date. XR tablet for prophylaxis would follow later, likely 2028+ if CHAPTER-3 is positive.
- Why 8/10
- Next hard catalyst is the CHAPTER-3 Phase 3 topline data readout for the prophylactic XR formulation, expected in Q3 2026 (within ~3 months). This is a pivotal binary readout for the company's lead asset, which drives essentially all of PHVS's valuation. The NDA for the on-demand IR formulation (PDUFA April 23, 2027) serves as a second major catalyst within 12 months.
Two binary catalysts in the next ~9 months: CHAPTER-3 topline (Q3 2026) and the PDUFA decision on the IR capsule (April 23, 2027). The bigger swing factor near-term is CHAPTER-3 — a positive readout would validate the larger prophylactic market opportunity, while a miss would severely dent the thesis given that sebetralstat (KalVista) already beat deucrictibant to market as the first oral on-demand HAE therapy.
Price Chart
Executive Summary
Deucrictibant is Pharvaris' oral bradykinin B2 receptor antagonist for hereditary angioedema (HAE), developed in two formulations: an immediate-release capsule (PHVS416) for on-demand attack treatment and an extended-release tablet (PHVS719) for daily prophylaxis. The IR capsule produced strong Phase 3 RAPIDe-3 data (median symptom relief in 1.28 hours, p<0.0001) and the FDA accepted its NDA on July 6, 2026 with a PDUFA date of April 23, 2027. The XR tablet's Phase 3 CHAPTER-3 prophylaxis study completed enrollment and topline data is expected Q3 2026. While the clinical profile is compelling, deucrictibant faces a significant competitive disadvantage: KalVista's sebetralstat (EKTERLY) was already FDA-approved in July 2025 as the first oral on-demand HAE therapy and has a head start on commercial build-out. Analyst consensus is Strong Buy (9 Buy, 2 Hold) with a mean price target of $46.34, implying ~60% upside from ~$33.86.
How It Works
Deucrictibant is an oral pill that blocks the bradykinin B2 receptor. Bradykinin is a protein in the body that causes blood vessels to leak fluid, leading to sudden, painful swelling attacks in patients with hereditary angioedema (HAE). By blocking this receptor, deucrictibant prevents or stops these swelling attacks. It comes in two versions: an immediate-release capsule (works fast for treating attacks as they happen) and an extended-release tablet (taken daily to prevent attacks from occurring).
Trial Status
The IR capsule (PHVS416) completed the pivotal Phase 3 RAPIDe-3 study, which met all primary and 11 secondary endpoints (p<0.0001). The NDA was accepted by the FDA on July 6, 2026. The XR tablet (PHVS719) is being evaluated in the Phase 3 CHAPTER-3 prophylaxis study, which completed enrollment in early 2026 with topline data expected Q3 2026. Phase 2 CHAPTER-1 data showed 84.5% reduction in monthly HAE attack rate at 40mg.
The Two-Sided Case
Upcoming Catalysts
- CHAPTER-3 Phase 3 topline data for XR prophylaxis — expected Q3 2026 (within ~3 months)
- PDUFA decision for deucrictibant IR capsule — April 23, 2027
- Potential data presentations at medical conferences (e.g., AAAAI, EAACI)
- CREAATE study (Phase 3 for acquired angioedema AAE-C1INH) — earlier stage but expands addressable population
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Pharvaris N.V. Press Release PHVS ·Originating report