---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-020409"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2025-05-27T23:59:59+00:00"
generated_at: "2026-05-20T10:17:42.369966+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Rocket Pharma announces FDA clinical hold on Phase 2 Danon gene therapy trial after patient death

## Summary
- Patient in Phase 2 trial of RP-A501 experienced SAE (capillary leak syndrome) and later died due to acute systemic infection.
- FDA placed clinical hold on May 23, 2025; company had voluntarily paused dosing earlier.
- Root cause analysis focusing on novel immune suppression agent added to pre-treatment regimen for complement activation.
- Company unable to provide guidance on trial completion timing.
- Cash $318.2M as of March 31, 2025; expects to fund operations into 2027 with reduced spend.

## SEC filing metadata
- accession: 0001140361-25-020409
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2025-05-27T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036125020409/0001140361-25-020409-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036125020409/ef20049685_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-020409
- JSON: https://secwatch.observer/filing/0001140361-25-020409.json
- Plain text: https://secwatch.observer/filing/0001140361-25-020409.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.