Proven­tion Bio roller­coast­er con­tin­ues with gen­er­al­ly pos­i­tive re­marks from FDA ahead of Thurs­day’s ad­comm

Ear­ly last month, Proven­tion Bio’s shares cratered af­ter dis­clos­ing that the FDA found the phar­ma­co­ki­net­ic pro­files of its po­ten­tial type 1 di­a­betes drug, ac­quired from Eli Lil­ly, dif­fered when man­u­fac­tured by Lil­ly ver­sus Proven­tion.

At the time, the FDA said its con­cerns meant that it was not ready to start post-mar­ket­ing and la­bel dis­cus­sions with the com­pa­ny.

But now, two days ahead of the FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee meet­ing to dis­cuss the drug, known as teplizum­ab, the FDA sound­ed a rel­a­tive­ly pos­i­tive tone on safe­ty and ef­fi­ca­cy. The com­pa­ny’s stock was up about 30% ear­ly Tues­day.

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