Regenxbio plunges as FDA places hold on Hunter syndrome gene therapy
24/08/2026 12:45
BUZZ-Regenxbio plunges as FDA places hold on Hunter syndrome gene therapy ** Shares of drug developer Regenxbio RGNX.O fall 25% to $8.08 premarket
** 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
** Co says all five patients remain clinically stable or show improvement, and doctors believe the findings are likely benign
** Does not expect to resubmit its U.S. approval application for RGX-121 in the near term, co says
** Earlier this year, the FDA had declined to approve RGX-121, citing uncertainty regarding the trial design
** As of last close, stock down 25.6% YTD
(Reporting by Kamal Choudhury in Bengaluru)
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