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STAT+: FDA pauses Regenxbio gene therapy trial again due to safety concerns

2 outlets - including Biopharmadive and Statnews - are covering this story. Investigators detected masses on the spines of five patients who received its Hunter syndrome treatment, leading to the program’s second clinical hold this year.
Covered by 2 outlets
All coverage · 2 articles
BioPharma Dive
·Aug 24, 15:55 UTC
Safety concerns spur FDA to again halt testing of Regenxbio gene therapy
Investigators detected masses on the spines of five patients who received its Hunter syndrome treatment, leading to the program’s second clinical hold this year.
STAT News
·Aug 24, 11:59 UTC
STAT+: FDA pauses Regenxbio gene therapy trial again due to safety concerns
The FDA put a hold on a Regenxbio gene therapy trial again after new safety concerns emerged.