Mo­tif Bio's turn­around quest for once-re­ject­ed an­tibi­ot­ic hits the CRL wall

For Mo­tif Bio, 2019 was go­ing to be all about the launch and roll­out of iclaprim. But a com­plete re­sponse let­ter from the FDA has shat­tered that dream and sent its stock crash­ing.

This is the sec­ond time reg­u­la­tors have said no to the an­tibi­ot­ic. The first re­jec­tion took place in 2009, when iclaprim was in the hands of a Roche spin­out named Arp­i­da, as ex­perts ex­pressed con­cern about QT pro­lon­ga­tion and a dis­pro­por­tion­ate num­ber of deaths, while point­ing to murky ef­fi­ca­cy.

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