Regenxbio plunges as FDA places hold on Hunter syndrome gene therapy
RGNX•Company says patients remain stable
All five patients remain clinically stable or show improvement, and doctors believe the findings are likely benign, the company said.
RGNX does not expect to resubmit its U.S. approval application for RGX-121 in the near term.
Earlier this year, the FDA had declined to approve RGX-121, citing uncertainty regarding the trial design.
Including session moves, the stock is down 44% year to date.
FDA places clinical hold on RGX-121
Shares of drug developer Regenxbio RGNX.O tumble 24.4% to a three-month low of $8.08.
The U.S. FDA places a clinical hold on Regenxbio's experimental gene therapy RGX-121 for Hunter syndrome after MRI scans identify small, symptom-free spinal abnormalities in five patients.
