Regenxbio (RGNX) Stock Drops 25% After FDA Places Clinical Hold on Gene Therapy
TLDR
- Regenxbio stock fell 25% to $8.05 after the FDA placed a clinical hold on its gene therapy RGX-121
- Five patients in an expanded MRI program showed asymptomatic nodules or cystic masses on their spines
- Findings were deemed non-serious and likely benign, but still triggered regulatory action
- Regenxbio no longer expects to resubmit its BLA for RGX-121 in the near term
- The company still plans to submit a BLA for its Duchenne candidate this quarter and release wet AMD data in Q4
Regenxbio stock dropped 25% to $8.05 on Monday after the FDA placed a clinical hold on RGX-121, its investigational gene therapy for Hunter syndrome. Trading was briefly halted ahead of the news.
The hold came after an expanded MRI monitoring program turned up asymptomatic findings in five patients. Each had a small nodule or cystic mass on their spine. All five had received injections of RGX-121 roughly three to six years earlier.
Researchers classified the findings as non-serious. Radiologists assessed them as likely benign, and there is no clinical or pathological evidence linking them directly to the therapy.
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