The presence for the first time of cardiopulmonary insufficiency/respiratory symptoms in an adverse event report may be what led the US Food and Drug Administration to put Solid Biosciences Inc.’ candidate DMD gene therapy, SGT-001, on clinical hold for the second time.
Adverse Event Concerns With Solid Biosciences' Candidate DMD Gene Therapy
Cardiopulmonary Symptoms May Have Triggered Clinical Hold
The US FDA has for the second time placed a clinical hold on Solid Biosciences’ potential gene therapy for Duchenne muscular dystrophy, a move linked to a 70% decline in the company’s share price. The company had reported a serious adverse event in a patient treated with higher doses of the viral vector-delivered gene therapy.
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