FDA re­jects Check­point Ther­a­peu­tic­s' PD-L1 drug cosi­be­limab over man­u­fac­tur­ing is­sues

Check­point Ther­a­peu­tics’ an­ti-PD-L1 an­ti­body has been turned down by the FDA due to man­u­fac­tur­ing is­sues, send­ing its share price down 45% pre­mar­ket on Mon­day.

The com­pa­ny, though, is still hope­ful about win­ning ap­proval in 2024 be­cause the re­jec­tion is “sole­ly due to” in­spec­tion find­ings at its con­tract man­u­fac­tur­ing or­ga­ni­za­tion, ac­cord­ing to a press re­lease. The com­plete re­sponse let­ter “on­ly cites find­ings that arose dur­ing a mul­ti-spon­sor in­spec­tion” of that man­u­fac­tur­er “as ap­prov­abil­i­ty is­sues to ad­dress in a re­sub­mis­sion.”

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