FDA Places Full Clinical Hold on Solid Biosciences Trial for DMD Gene Therapy

The FDA has imposed a full clinical hold on Solid Biosciences’ Phase I/II trial for its lead candidate, the Duchenne muscular dystrophy (DMD) gene therapy SGT-001, the company acknowledged.IGNITE DMD had been on a partial clinical hold since November pending submission to the FDA of “additional CMC [chemistry, manufacturing, and control] information that demonstrates that manufacturing capacity and product attributes can support the high-dose group,” Solid disclosed in a Januar