---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-007462"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2024-02-13T23:59:59+00:00"
generated_at: "2026-06-06T03:06:59.297915+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA extends Rocket Pharma's KRESLADI BLA review to June 30, 2024; no advisory committee needed

## Summary
- FDA extended Priority Review by 3 months to June 30, 2024 to review clarifying CMC information submitted in response to FDA requests.
- FDA confirmed no advisory committee meeting will be held for KRESLADI.
- CEO Gaurav Shah expressed confidence in collaboration with FDA and commitment to making therapy available quickly.
- Phase 1/2 trial showed 100% overall survival at 12 months post-infusion for all nine patients; endpoints met.
- KRESLADI (marnetegragene autotemcel) is for severe Leukocyte Adhesion Deficiency-I (LAD-I).

## SEC filing metadata
- accession: 0001140361-24-007462
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2024-02-13T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036124007462/0001140361-24-007462-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036124007462/ef20021579_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-007462
- JSON: https://secwatch.observer/filing/0001140361-24-007462.json
- Plain text: https://secwatch.observer/filing/0001140361-24-007462.txt

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