Regenxbio faces second FDA clinical hold, delaying Hunter syndrome gene therapy filing
read at Endpoints ↗RegulatoryNegative
Regenxbio announced that its gene therapy for Hunter syndrome has received a second clinical hold from the FDA this year.
The company said it no longer expects to submit an NDA or seek approval in the near future because of the hold.
The hold underscores ongoing regulatory challenges for the program and may delay any potential market entry.
source
This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “Regenxbio hit with another clinical hold for Hunter syndrome gene therapy”
read at Endpoints ↗82 words · retrieved Aug 24
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