Keyword: Solid Biosciences
The first patient treated with the higher dose of DMD gene therapy SGT-001 suffered a serious adverse event, wiping 35% off Solid’s stock price.
Solid Bio’s run of negative news is continuing with another setback for its Duchenne muscular dystrophy gene therapy.
The data, taken from three patients, showed a 38% increase in a muscle protein that boys with DMD usually lack.
The FDA lifted the second of two clinical holds on Solid Bio’s Duchenne muscular dystrophy trial, following safety and manufacturing concerns.
Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.
The FDA has extended its partial hold on Solid Bio's phase 1/2 DMD trial to a full hold following a patient's hospitalization.