# FDA puts Regenxbio's Hunter syndrome gene-therapy trial on hold

_Published Monday, August 24, 2026 at 10:18 AM EDT · Policy · Latest · Tier 2 — Notable_

![Row of Falling Domino Stones Stopped by Red Domino Stone Over Black Background, Risk Management, Intervene or Prevention Concept, 3d Rendering — Primary](https://static.biospace.com/dims4/default/f5b9f57/2147483647/strip/true/crop/724x407+0+38/resize/1440x810!/quality/90/?url=https%3A%2F%2Fk1-prod-biospace.s3.us-east-2.amazonaws.com%2Fbrightspot%2F5d%2Fac%2F347a790a4e478c197afb5ace5312%2Fdominoes.jpg)

The FDA placed a clinical hold on REGENXBIO's RGX-121 trial after MRI scans found small nodules or cystic masses in the spines of five of 48 participants in the CAMPSIITE study, according to the company. REGENXBIO said the findings were asymptomatic and investigators considered them nonserious, but it no longer expects to resubmit its biologics license application soon. The agency had rejected the application in February; in June it had said existing data could support an accelerated-approval resubmission.

## Sources

- [BioSpace](https://www.biospace.com/fda/regenxbios-hunter-syndrome-gene-therapy-hit-by-fda-hold-stymieing-resubmission-plans)

---
Canonical: https://techandbusiness.org/newswire/GRV4Nkpgg_bsHvIbaii8eB
Published: 2026-08-24T14:18:21.425Z
Story chronology: 2026-08-24T13:44:42.172Z
Retrieved: 2026-10-08T20:43:41.554Z
Publisher: Tech & Business (techandbusiness.org)