---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-011573"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2026-03-27T23:59:59+00:00"
generated_at: "2026-05-15T08:32:14.242398+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Rocket's gene therapy KRESLADI for severe LAD-I; Rare Pediatric PRV granted

## Summary
- KRESLADI (marnetegragene autotemcel) approved for pediatric severe LAD-I with no HLA-matched sibling donor.
- First FDA-approved gene therapy for severe LAD-I; accelerated approval based on CD18/CD11a expression.
- FDA granted Rocket a Rare Pediatric Disease Priority Review Voucher; company plans to evaluate monetization.
- Company to host investor conference call March 27 at 8:30 AM ET.
- Phase 1/2 study principal investigator Donald Kohn, M.D., highlights years of research culminating in approval.

## SEC filing metadata
- accession: 0001140361-26-011573
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2026-03-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1281895/000114036126011573/0001140361-26-011573-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036126011573/ef20069038_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-011573
- JSON: https://secwatch.observer/filing/0001140361-26-011573.json
- Plain text: https://secwatch.observer/filing/0001140361-26-011573.txt

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