FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Ther­a­peu­tics’ stock took a nasty hit this morn­ing af­ter the biotech put out word that the FDA had slapped a clin­i­cal hold on their top pro­gram for Duchenne mus­cu­lar dy­s­tro­phy. And now spec­u­la­tion is bounc­ing around Biotwit­ter that there could be a class ef­fect at work here that would im­pli­cate oth­er drug de­vel­op­ers in the freeze.

Dyne ex­ecs didn’t have a whole lot to say about why the FDA side­lined their IND for DYNE-251 in DMD while “re­quest­ing ad­di­tion­al clin­i­cal and non-clin­i­cal in­for­ma­tion for” the drug.

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