San­thera’s Duchenne drug hits a road­block at the FDA, and one an­a­lyst sees an­oth­er bad sign for Sarep­ta

Once again the FDA has tak­en a hard line on an ef­fort to seek a quick ap­proval for a new drug that treats Duchenne mus­cu­lar dy­s­tro­phy. And while it’s not Sarep­ta this time, at least one promi­nent an­a­lyst says the agency’s tough stance high­lights the odds of a loom­ing re­jec­tion.

It was San­thera’s turn to­day to dis­ap­point in­vestors. The Swiss biotech an­nounced this morn­ing that the agency will re­quire in­ves­ti­ga­tors to fin­ish an­oth­er, con­fir­ma­to­ry Phase III study for their Duchenne’s drug, putting off any prospect of a U.S. ap­proval by more than three years.

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