# Deucrictibant immediate-release (IR) capsule, 20 mg PDUFA Event: On-demand treatment of hereditary angioedema attacks

Canonical URL: https://biopharmsignal.com/pdufa-calendar/PHVS/deucrictibant-ir-on-demand-hereditary-angioedema

Ticker: PHVS

Company: Pharvaris

Event date: 2027-04-23

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned April 23, 2027 as the PDUFA target action date for deucrictibant IR’s NDA.

## Event Timeline

### April 23, 2027 — FDA decision expected

FDA assigned April 23, 2027 as the PDUFA target action date for deucrictibant IR’s NDA.

[Pharvaris — NDA acceptance and PDUFA date](https://ir.pharvaris.com/news-releases/news-release-details/pharvaris-announces-fda-acceptance-new-drug-application)

### July 6, 2026 — FDA accepted the NDA for review

FDA accepted the NDA for the oral immediate-release capsule for on-demand treatment of hereditary angioedema attacks.

[Pharvaris — NDA acceptance](https://ir.pharvaris.com/news-releases/news-release-details/pharvaris-announces-fda-acceptance-new-drug-application)

### July 6, 2026 — RAPIDe-3 Phase 3 data supported the filing

RAPIDe-3 met its primary endpoint and all 11 secondary efficacy endpoints; median time to symptom relief was 1.28 hours.

[Pharvaris — RAPIDe-3 results summary](https://ir.pharvaris.com/news-releases/news-release-details/pharvaris-announces-fda-acceptance-new-drug-application)

## Regulatory Designations

- Orphan Drug FDA: [Pharvaris — FDA Orphan Drug designation](https://ir.pharvaris.com/news-releases/news-release-details/pharvaris-announces-positive-topline-data-rapide-3-pivotal-study)

## Related Pages

- PHVS PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/PHVS.md

- PHVS company profile: https://biopharmsignal.com/company/PHVS.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-10-05 — Real-World Analysis Highlighting HAE Disease Experience and Gaps in Treatment Satisfaction Published in Advances in Therapy: https://biopharmsignal.com/news/PHVS/real-world-analysis-highlighting-hae-disease-experience-and-gaps-in-treatment-sa-30d14e71.md

- 2026-09-08 — Pharvaris Announces Positive Topline Data from CHAPTER-3 Pivotal Study of Deucrictibant XR for Prophylaxis of HAE Attacks: https://biopharmsignal.com/news/PHVS/pharvaris-announces-positive-topline-data-from-chapter-3-pivotal-study-of-deucri-fc0b4a56.md

- 2026-09-03 — Pharvaris Presents Translational, Nonclinical, and Clinical Data at Bradykinin Symposium 2026: https://biopharmsignal.com/news/PHVS/pharvaris-presents-translational-nonclinical-and-clinical-data-at-bradykinin-sym-abec87ce.md

- 2026-08-12 — Pharvaris Reports Second Quarter 2026 Financial Results and Provides Business Update: https://biopharmsignal.com/news/PHVS/pharvaris-reports-second-quarter-2026-financial-results-and-provides-business-up-d4220488.md

- 2026-08-06 — Assessment of AAE-C1INH Disease Burden and Validation of Clinical Trial Endpoints Published in Frontiers in Immunology: https://biopharmsignal.com/news/PHVS/assessment-of-aae-c1inh-disease-burden-and-validation-of-clinical-trial-endpoint-6809dac5.md