---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-038030"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2025-10-14T23:59:59+00:00"
generated_at: "2026-05-17T03:51:17.859248+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Rocket Pharma: FDA accepts BLA resubmission for KRESLADI gene therapy; PDUFA March 28, 2026

## Summary
- FDA accepted BLA resubmission for KRESLADI (marne-cel) for severe LAD-I; PDUFA target date March 28, 2026.
- Phase 1/2 study showed 100% overall survival at 12 months; all endpoints met; well tolerated with no treatment-related SAEs.
- Company eligible for Rare Pediatric Disease Priority Review Voucher if KRESLADI is approved.
- Severe LAD-I is near-uniformly fatal in childhood; only current treatment is bone marrow transplant with substantial morbidity.

## SEC filing metadata
- accession: 0001140361-25-038030
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2025-10-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036125038030/0001140361-25-038030-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036125038030/ef20057000_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-038030
- JSON: https://secwatch.observer/filing/0001140361-25-038030.json
- Plain text: https://secwatch.observer/filing/0001140361-25-038030.txt

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