# Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings

> **Newsylist Open Intelligence Dossier** · First detected: 2026-08-24 22:29 UTC · Category: Business · Sources: 2 · Current Velocity: 0.71

## Multi-Source Evidence Table
| Source Outlet | Headline | Published (UTC) | Verification URL |
|---|---|---|---|
| BioSpace | REGENXBIO’s Hunter syndrome gene therapy hit by FDA hold, stymieing resubmission plans | 2026-08-24 11:51 | [Source Link](https://news.google.com/rss/articles/CBMiswFBVV95cUxQR0U5YjhlOU5hRExHNWJyczIxNXBDd21JMmQzZDZfalVzVU44UkMwN21yc3A1UXRiX0lpbkpfMkZZNjl4M1YzeTdnVlJ2VDY2U0w2YWVrZWtMb0x2VWpvaGVuSTZuYzlQcDI2VjhHNVgzUVZKeWdHYk9zX0JMZVY3RUdULWVqdzZlNjREWjBtY2gtV1B4b09HUm11V29CUlZWaldidlA0Nld4NWo2Ty00ODZjNA?oc=5) |
| BioPharma Dive | Safety concerns spur FDA to again halt testing of Regenxbio gene therapy | 2026-08-24 11:51 | [Source Link](https://news.google.com/rss/articles/CBMikgFBVV95cUxOSmZGZ0Y1Ym41MWNEeURwekxkVlJxSTJEc1o1WHRzUFRxQXNwV2s1VlV3YU1hYlhQSTRMRFJIVU0xYUZGbXpFUTNBSXpoeWlNY2lSSk5VdkV4Zkw5aHJBTkMzTUliQVpQcGU1eHhDcTBpMkpwZ2pjS3A0QnNEUmpXZDJOT0VBUVk1eFVPRkxpZjNDUQ?oc=5) |

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