Full FDA let­ter in hand, Sol­id Bio says it's work­ing to re­verse clin­i­cal hold on its DMD gene ther­a­py

Faced with skep­ti­cal in­vestors and low share prices ever since the FDA slapped a clin­i­cal hold on its gene ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy, Sol­id Bio­sciences put out a note to­day de­tail­ing how it’s ad­dress­ing the agency’s con­cerns. The up­date al­so came with pos­i­tive news: If the PhI/II tri­al re­sumes, the biotech would be able to test both the high and low dos­es of the treat­ment.

In a full clin­i­cal hold let­ter Sol­id Bio $SLDB re­ceived to­day, the FDA laid out what it would take to re­sume the tri­al: an as­sess­ment of the un­der­ly­ing caus­es of the ad­verse event, the pa­tient’s clin­i­cal sta­tus and lab­o­ra­to­ry pa­ra­me­ters, as well as any new mea­sures to ad­dress pa­tient safe­ty.

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