BioPharma Dive

Regenxbio gene therapy trials suspended by FDA over safety worries

The development of a brain tumor in a study participant led regulators to suspend a Hurler syndrome therapy in early testing ...
Investor's Business Daily on MSN

The 'confusing and unexpected' update that slammed Regenxbio stock

The FDA, on Wednesday, unexpectedly placed two of Regenxbio's experimental gene therapies on hold after a patient developed a ...
Healio

FDA places clinical holds on gene therapies for rare neurodevelopmental conditions

The FDA has placed clinical holds on a pair of investigational gene therapies developed to address two rare neurodevelopmental disorders in children, according to the manufacturer. In a press release, ...
Becker's Hospital Review

FDA puts hold on gene therapy trials after brain tumor

After finding an intraventricular tumor in one clinical trial participant, the FDA placed a clinical hold on an experimental ...
BioSpace

REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval

The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which ...

Regenxbio selloff ‘an overreaction’ to clinical hold, says Leerink

After Regenxbio (RGNX) disclosed the FDA put a clinical hold on RGX-111 for Hurler syndrome and on the RGX-121 study for Hunter syndrome, Leerink said the roughly 30% premarket selloff in shares ...