---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-037163"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2025-10-03T23:59:59+00:00"
generated_at: "2026-05-17T04:42:42.484433+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rocket Pharma withdraws BLA for RP-L102 (Fanconi anemia gene therapy) as part of corporate prioritization

## Summary
- Voluntarily withdrew BLA for RP-L102 (mozafancogene autotemcel) from FDA on October 3, 2025.
- Withdrawal follows prior MAA withdrawal to European Medicines Agency in July 2025 and cessation of new internal investment in RP-L102 in July 2025.
- Decision based on business and strategic considerations; no safety or efficacy concerns noted.
- Company will explore external partnership opportunities to potentially advance RP-L102 in the future.
- Rocket is focusing resources on programs with clearest regulatory and commercial pathways.

## SEC filing metadata
- accession: 0001140361-25-037163
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2025-10-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036125037163/0001140361-25-037163-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036125037163/ef20056613_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-037163
- JSON: https://secwatch.observer/filing/0001140361-25-037163.json
- Plain text: https://secwatch.observer/filing/0001140361-25-037163.txt

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