India, Aug. 24 -- REGENXBIO Inc. (RGNX) shares plunged 26% to $7.96 in Monday's trading after the company said the FDA placed a clinical hold on its investigational RGX-121 gene therapy for MPS II, or Hunter Syndrome.
The clinical hold followed the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE study. The patients, who received RGX-121 approximately three to six years ago, remain clinically well, with overall stability to improvement in neurocognitive and neurobehavioral assessments.
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