---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-026132"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2025-07-17T23:59:59+00:00"
generated_at: "2026-05-18T05:55:08.740611+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA grants RMAT designation to Rocket Pharma's RP-A601 gene therapy for PKP2-ACM

## Summary
- FDA granted RMAT designation for RP-A601 (AAV-based gene therapy) for PKP2-arrhythmogenic cardiomyopathy.
- RMAT provides expedited FDA review, early interactions, and potential accelerated approval.
- Phase 1 data: two patients with low baseline PKP2 showed 110% and 398% increases in protein expression.
- Improvements in right ventricular function, ventricular arrhythmias, and KCCQ-12 scores (34-41 pts).
- Fifth RMAT designation for Rocket; favorable safety with no dose-limiting toxicities.

## SEC filing metadata
- accession: 0001140361-25-026132
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2025-07-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036125026132/0001140361-25-026132-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036125026132/ef20052120_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-026132
- JSON: https://secwatch.observer/filing/0001140361-25-026132.json
- Plain text: https://secwatch.observer/filing/0001140361-25-026132.txt

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