---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-273467"
form_type: "8-K"
ticker: "RGNX"
cik: "0001590877"
company_name: "REGENXBIO Inc."
filed_at: "2024-12-09T23:59:59+00:00"
generated_at: "2026-05-29T05:39:06.715869+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# REGENXBIO initiates pivotal phase of RGX-202 Duchenne trial with positive functional data; signs $150M ATM facility

## Summary
- First five patients in Phase I/II showed stable/improved function on NSAA and timed tests, exceeding external natural history controls.
- FDA alignment achieved on accelerated approval pathway; BLA submission expected in 2026.
- Biomarker data: RGX-202 microdystrophin expression highest reported; no serious adverse events.
- New ATM sales agreement with Leerink Partners for up to $150M common stock, replacing prior BofA facility.
- Pivotal trial enrolling ambulatory patients aged 1+, first patient dosed; includes younger boys aged 1-3.

## SEC filing metadata
- accession: 0001193125-24-273467
- form_type: 8-K
- ticker: RGNX
- cik: 0001590877
- company_name: REGENXBIO Inc.
- filed_at: 2024-12-09T23:59:59+00:00
- event_type: other_material
- 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/1590877/000119312524273467/0001193125-24-273467-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590877/000119312524273467/d837203d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-273467
- JSON: https://secwatch.observer/filing/0001193125-24-273467.json
- Plain text: https://secwatch.observer/filing/0001193125-24-273467.txt

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