Mi­rati gets a stan­dard re­view for its 'break­through' KRAS drug. And that is caus­ing some hand wring­ing

Af­ter the mar­ket close on Mon­day, Mi­rati is­sued a state­ment that the FDA had ac­cept­ed its ap­pli­ca­tion for their KRAS drug ada­gra­sib and is giv­ing it a stan­dard 10-month re­view, set­ting a PDU­FA date way out to­ward the end of the year.

That’s not ex­act­ly what Mi­rati in­vestors were look­ing for. Play­ing catch-up in lung can­cer with Am­gen — which got an ac­cel­er­at­ed ap­proval for so­tora­sib (Lumakras) fol­low­ing a fe­ro­cious 3-year clin­i­cal cam­paign and is now pur­su­ing a con­fir­ma­to­ry study of the drug — Mi­rati was clear­ly hop­ing to get the short, snap re­view and look to get out in the mar­ket in the mid­dle of the year. And a STAT piece ini­tial­ly in­di­cat­ed that the ear­ly Lumakras ap­proval had trig­gered the length­i­er re­view at Mi­rati — some­thing that was then clar­i­fied with a re­mark that the com­pa­ny was not told why they got the stan­dard look-see.

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