FDA keeps Sol­id Bio's trou­bled Duchenne MD gene ther­a­py on clin­i­cal lock­down in lat­est set­back

Much-ma­ligned Sol­id Bio­sciences re­ceived yet an­oth­er spate of bad news late Fri­day re­gard­ing its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py pro­gram.

It’s been al­most nine months since the FDA an­nounced a sec­ond clin­i­cal hold on Sol­id Bio’s Phase I/II tri­al for an AAV-based Duchenne MD treat­ment. And af­ter ex­tend­ing that hold in May, US reg­u­la­tors again de­cid­ed they need­ed more in­fo with an­oth­er ex­ten­sion on Fri­day.

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