RegenxBio runs into partial hold for anti-VEGF gene therapy as FDA investigates delivery device
Issues with a delivery device are slowing down RegenxBio’s clinical plans for one of its lead gene therapies.
In its Q3 update, RegenxBio informed investors of a partial clinical hold the FDA has slapped on RGX-314 while regulators review certain third-party commercially-available devices the biotech uses to deliver its treatment. As a result, RegenxBio won’t be able to start its planned Phase IIb trial for wet age-related macular degeneration or file an IND for a Phase II diabetic retinopathy study until early 2020.
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