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

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.