With Back-To-Back FDA Holds, Solid Hopes To Regain Footing For Duchenne Candidate
Executive SummaryThe US FDA wants more information on the first patient given SGT-001, who was hospitalized with a reduced platelet count after dosing. Solid says the patient is doing well and hopes to reply to the FDA's concerns within weeks.
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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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