---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-109829"
form_type: "8-K"
ticker: "RGNX"
cik: "0001590877"
company_name: "REGENXBIO Inc."
filed_at: "2025-08-18T23:59:59+00:00"
generated_at: "2026-05-17T11:55:53.797325+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA date for RGX-121 BLA to February 8, 2026

## Summary
- PDUFA goal date extended from Nov 9, 2025 to Feb 8, 2026 for review of additional 12-month data from pivotal study (n=13).
- No safety concerns raised; pre-license inspection completed with no observations.
- Company to present updated pivotal data at ICIEM meeting in September 2025; commercial launch plans remain on track.
- RGX-121 would be first potential one-time therapy for MPS II (Hunter syndrome); holds FDA Orphan, Rare Pediatric, Fast Track, RMAT designations.

## SEC filing metadata
- accession: 0000950170-25-109829
- form_type: 8-K
- ticker: RGNX
- cik: 0001590877
- company_name: REGENXBIO Inc.
- filed_at: 2025-08-18T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1590877/000095017025109829/0000950170-25-109829-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1590877/000095017025109829/rgnx-20250818.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-109829
- JSON: https://secwatch.observer/filing/0000950170-25-109829.json
- Plain text: https://secwatch.observer/filing/0000950170-25-109829.txt

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