FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Sol­id Bio­sciences con­tin­ues to be plagued by safe­ty is­sues.

Close to 18 months af­ter the gene ther­a­py biotech was able to quick­ly shed an FDA hold on their lead Duchenne mus­cu­lar dy­s­tro­phy pro­gram for SGT-001, reg­u­la­tors have stepped back in to force an­oth­er halt af­ter an­oth­er pa­tient was hit hard by a set of se­ri­ous ad­verse events re­mark­ably sim­i­lar to the first set.

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