FDA doc re­veals agency charged Im­munomedics with da­ta in­tegri­ty breach af­ter Au­gust plant in­spec­tion

Hav­ing spent over three decades with­out an ap­proval, Im­munomedics has a trou­bled past that cul­mi­nat­ed in a man­age­ment shake­up at the be­hest of an ac­tivist share­hold­er cam­paign that was meant to re­ju­ve­nate the com­pa­ny’s for­tunes. But that hope was shat­tered when the FDA re­ject­ed the com­pa­ny’s breast can­cer drug in Jan­u­ary, cit­ing man­u­fac­tur­ing is­sues.

To be sure, the com­pa­ny was not ex­pect­ing the re­jec­tion. It hired a sales force back in No­vem­ber in an­tic­i­pa­tion of the Jan­u­ary ap­proval and told an­a­lysts in De­cem­ber that man­u­fac­tur­ing is­sues the US health reg­u­la­tor had flagged in Au­gust had since been ad­dressed.

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