---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-363786"
form_type: "8-K"
ticker: "RGNX"
cik: "0001590877"
company_name: "REGENXBIO Inc."
filed_at: "2026-08-24T21:20:14+00:00"
generated_at: "2026-08-24T21:22:10.193304+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA clinical hold on REGENXBIO's RGX-121 for MPS II; BLA resubmission not expected near term

## Summary
- FDA clinical hold on RGX-121 after asymptomatic spine MRI findings in 5 CAMPSIITE study participants.
- REGENXBIO does not expect to resubmit RGX-121 BLA in near term; longer follow-up and data analysis needed.
- All five participants clinically stable/improving; findings deemed nonserious, likely benign by investigators.
- Company reaffirms Duchenne BLA submission this quarter and wet AMD pivotal data in Q4.
- Hold follows earlier RGX-111 clinical hold; expanded MRI monitoring to include brain and spine.

## SEC filing metadata
- accession: 0001193125-26-363786
- form_type: 8-K
- ticker: RGNX
- cik: 0001590877
- company_name: REGENXBIO Inc.
- filed_at: 2026-08-24T21:20:14+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/0001193125-26-363786-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590877/000119312526363786/rgnx-20260824.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-363786
- JSON: https://secwatch.observer/filing/0001193125-26-363786.json
- Plain text: https://secwatch.observer/filing/0001193125-26-363786.txt

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