FDA isn't lifting the clinical hold on Solid Bio's Duchenne MD gene therapy just yet — but is there a silver lining?
It may now be close to a year before Solid Bio can resume human testing on its lead gene therapy program.
The clinical hold that the FDA slapped on the program last November in the wake of a severe adverse event marked the second such interruption for the Phase I/II IGNITE DMD study, which was testing SGT-001 in a small cohort of patients with Duchenne muscular dystrophy. While Solid Bio resolved the first hold within three months, this time around regulators demanded more data.
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