Trou­ble brew­ing for Proven­tion? Shares crater af­ter FDA says their teplizum­ab drug pro­file does­n't match that from for­mer own­er Eli Lil­ly

Proven­tion Bio ac­quired the for­mer Eli Lil­ly drug teplizum­ab a few years ago, hop­ing to bring the ex­per­i­men­tal drug back from the dead in type 1 di­a­betes af­ter it flamed out in a piv­otal di­a­betes study un­der­tak­en by the Big Phar­ma more than 10 years ago. But Proven­tion is see­ing trou­bled wa­ters ahead fol­low­ing new feed­back from the FDA last week.

The biotech re­vealed Thurs­day that reg­u­la­tors ex­pressed con­cerns over the can­di­date’s phar­ma­co­ki­net­ics da­ta and com­pa­ra­bil­i­ty con­tained with­in Proven­tion’s da­ta pack­age sub­mit­ted to the FDA. Reg­u­la­tors are as­sert­ing the PK pro­files of the drug man­u­fac­tured by Lil­ly and by Proven­tion are not the same, and asked for more da­ta on April 2.

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