---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-222768"
form_type: "8-K"
ticker: "RGNX"
cik: "0001590877"
company_name: "REGENXBIO Inc."
filed_at: "2026-05-14T11:15:16+00:00"
generated_at: "2026-05-14T11:21:06.247242+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# REGENXBIO RGX-202 Phase III meets primary endpoint (p<0.0001); Q1 net loss $90.1M

## Summary
- Primary endpoint achieved: 93% of patients >10% microdystrophin expression at Week 12 (p<0.0001); average expression 71.1%.
- Significant correlation between microdystrophin expression and functional improvement (NSAA, p=0.0002); supports surrogate endpoint for accelerated approval.
- Q1 2026 net loss $90.1M ($1.72/share) vs prior-year net income $6.1M; revenue fell to $6.4M from $89.0M (prior year milestone).
- Cash $150.5M at March 31 (vs $240.9M Dec 31); runway into early 2027; expects $100M AbbVie milestone upon first DR patient dosed in Q2 2026.
- FDA lifted clinical hold on RGX-121; company preparing for RGX-202 BLA submission targeting potential accelerated approval in 2027.

## SEC filing metadata
- accession: 0001193125-26-222768
- form_type: 8-K
- ticker: RGNX
- cik: 0001590877
- company_name: REGENXBIO Inc.
- filed_at: 2026-05-14T11:15:16+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590877/000119312526222768/0001193125-26-222768-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590877/000119312526222768/rgnx-20260514.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-222768
- JSON: https://secwatch.observer/filing/0001193125-26-222768.json
- Plain text: https://secwatch.observer/filing/0001193125-26-222768.txt

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