Pharvaris N.V. PHVS
Pharvaris N.V. (Nasdaq: PHVS) is a rare genetic drug developer. Its lead program, Deucrictibant IR capsule (on-demand), is in Phase 3 for On-demand treatment of hereditary angioedema (HAE) attacks. Its next catalyst on record is Deucrictibant IR: FDA PDUFA action date for on-demand HAE NDA (April 23, 2027).
Upcoming catalysts
- April 23, 2027Deucrictibant IR — FDA PDUFA action date for on-demand HAE NDA
In July 2026, the U.S. Food and Drug Administration (FDA) accepted to review the Company's New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks, with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027.
Next further out: Deucrictibant XR (CREAATE) — Topline data from Part 1 of CREAATE in AAE-C1INH (Q1 2027). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Deucrictibant IR capsule (20 mg) - NDA under FDA review, MAA under EMA review | On-demand treatment of HAE attacks | small molecule | Phase 3 |
| Deucrictibant XR tablet (40 mg/day) - CHAPTER-3 positive Phase 3, CHAPTER-4 OLE ongoing | Prophylaxis of HAE attacks | small molecule | Phase 3 |
| Deucrictibant - CREAATE pivotal Phase 3 | Acquired angioedema due to C1-INH deficiency (AAE-C1INH), prophylaxis and on-demand | small molecule | Phase 3 |
Recent results and decisions
- Sep 8, 2026met CHAPTER-3 met primary endpoint: 83% reduction in mean monthly HAE attack rate vs placebo (p<0.0001), 87% in HAE type 1/2; all secondary endpoints met.
The primary endpoint and all secondary efficacy endpoints were met with statistical significance.
Filing - Aug 12, 2026accepted FDA accepted NDA for deucrictibant IR in July 2026 with PDUFA date April 23, 2027.
In July 2026, the U.S. Food and Drug Administration (FDA) accepted to review the Company’s New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks, with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027.
Filing - Aug 12, 2026accepted EMA validated the MAA for deucrictibant IR in July 2026 and began formal centralized review.
In July 2026, the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for deucrictibant IR and began its formal review of the MAA under the centralized procedure.
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.