US FDA Declines to Approve Regenxbio's Gene Therapy for ...

Dismay as FDA blocks Regenxbio's Hunter syndrome therapy

The FDA said it needs more information before it can approve Regenxbio's gene therapy for Hunter syndrome, in a devastating decision for patients

Why Is REGENXBIO Stock Falling Today? - Regenxbio (NASDAQ:RGNX)

REGENXBIO shares fall after the FDA issues a response letter on its Hunter syndrome gene therapy, raising trial design concerns and pushing the approval timeline.

FDA rejects Regenxbio’s rare-disease gene therapy

RGX-121 is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome

US FDA declines to approve Regenxbio's gene therapy for ...

REGENXBIO's MPS II Gene Therapy RGX-121 Hit With CRL | NeurologyLive - Clinical Neurology News and Neurology Expert Insights

FDA issued a CRL for gene therapy RGX-121 in Hunter syndrome, citing trial design and biomarker doubts; REGENXBIO seeks a meeting with the agency and resubmission.

REGENXBIO receives FDA response for RGX-121 application

REGENXBIO has received a CRL from the US FDA related to its BLA for RGX-121 to treat MPS II, also called hunter syndrome.