---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-031749"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2024-06-28T23:59:59+00:00"
generated_at: "2026-06-01T00:27:54.206354+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Rocket Pharma receives FDA Complete Response Letter for KRESLADI BLA; limited CMC info requested

## Summary
- FDA issued Complete Response Letter for KRESLADI (marne-cel) BLA; requested limited additional CMC information.
- Company met with FDA CBER senior leaders to align on scope of additional CMC info to support approval expeditiously.
- Phase 1/2 data: 100% overall survival at 12 months in 9 patients; all endpoints met; no treatment-related serious AEs.

## SEC filing metadata
- accession: 0001140361-24-031749
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2024-06-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036124031749/0001140361-24-031749-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036124031749/ef20031912_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-031749
- JSON: https://secwatch.observer/filing/0001140361-24-031749.json
- Plain text: https://secwatch.observer/filing/0001140361-24-031749.txt

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