---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-23-046302"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2023-10-02T23:59:59+00:00"
generated_at: "2026-06-10T06:17:55.666190+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts BLA and grants Priority Review for Rocket's RP-L201 gene therapy for severe LAD-I; PDUFA March 31, 2024

## Summary
- PDUFA target action date set for March 31, 2024.
- RP-L201 has FDA RMAT, Rare Pediatric, Fast Track, and Orphan Drug designations.
- Rocket eligible for Priority Review Voucher if RP-L201 is approved.
- Phase 1/2 data: 100% overall survival at ≥12 months for all nine patients; symptoms resolved.
- RP-L201 is a lentiviral vector-based gene therapy for severe LAD-I, a fatal childhood immune disorder.

## SEC filing metadata
- accession: 0001140361-23-046302
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2023-10-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1281895/000114036123046302/0001140361-23-046302-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036123046302/ef20011759_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-23-046302
- JSON: https://secwatch.observer/filing/0001140361-23-046302.json
- Plain text: https://secwatch.observer/filing/0001140361-23-046302.txt

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