---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-036563"
form_type: "8-K"
ticker: "RCKT"
cik: "0001281895"
company_name: "ROCKET PHARMACEUTICALS, INC."
filed_at: "2026-09-15T11:06:51+00:00"
generated_at: "2026-09-15T11:10:07.490286+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Rocket Pharma gets FDA alignment on pivotal Danon trial; 12-patient cohort path clear

## Summary
- FDA confirms 12-patient pivotal population for RP-A501; first 3 treated under modified protocol count toward it.
- Recalibrated dose 3.8e13 GC/kg; no thrombotic microangiopathy or capillary leak in first 3 patients.
- Co-primary endpoints: myocardial LAMP2 expression and 10% reduction in left ventricular mass index at 12 months, supporting potential accelerated approval.
- Company expects to complete dosing of remaining 9 patients by mid-2027.
- Virtual investor webinar on Danon disease program scheduled for Oct 6, 2026 at 4:30 p.m. ET.

## SEC filing metadata
- accession: 0001140361-26-036563
- form_type: 8-K
- ticker: RCKT
- cik: 0001281895
- company_name: ROCKET PHARMACEUTICALS, INC.
- filed_at: 2026-09-15T11:06:51+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1281895/000114036126036563/0001140361-26-036563-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1281895/000114036126036563/ef20082010_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-036563
- JSON: https://secwatch.observer/filing/0001140361-26-036563.json
- Plain text: https://secwatch.observer/filing/0001140361-26-036563.txt

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