Keyword: Solid Biosciences
Amid clinical holds, manufacturing concerns, safety issues and downsized IPOs, Solid Biosciences is bloodletting from its staffers.
A new clinical hold is the latest setback for Solid Biosciences and the development of its gene therapy for Duchenne muscular dystrophy.
One of the first six people to receive the treatment was hospitalized with acute renal injury, leading analysts to talk down Pfizer’s chances.
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.