$RGNX (REGENXBIO) — 8-K: FDA clinical hold on RGX-121 after asymptomatic spine MRI findings in five patients

The FDA placed a clinical hold on RGX-121 for MPS II after asymptomatic spine MRI findings in five CAMPSIITE study participants. REGENXBIO does not expect to resubmit the RGX-121 Biologics License Application in the near term. All five participants continue to do well clinically with overall stability to improvement on neurocognitive and neurobehavioral assessments. The company remains on track for its Duchenne BLA submission this quarter and wet AMD pivotal data in Q4.

The FDA placed a clinical hold on RGX-121 for MPS II after asymptomatic spine MRI findings in five CAMPSIITE study participants. REGENXBIO does not expect to resubmit the RGX-121 Biologics License Application in the near term. All five participants continue to do well clinically with overall stability to improvement on neurocognitive and neurobehavioral assessments. The company remains on track for its Duchenne BLA submission this quarter and wet AMD pivotal data in Q4.