Biotech's shares rout­ed af­ter the FDA de­mands new tri­al, rais­es safe­ty and end­point is­sues in sur­prise CRL

A small biotech that’s been la­bor­ing long and hard on an oral chemo pro­gram for metasta­t­ic breast can­cer was slammed hard on Mon­day morn­ing, los­ing more than half of its mar­ket cap af­ter re­veal­ing that the FDA had is­sued a sur­prise CRL with some harsh new hur­dles in place.

Athenex $AT­NX says that reg­u­la­tors stiff-armed its ap­pli­ca­tion for oral pa­cli­tax­el and ence­quidar — a marked set­back af­ter win­ning a pri­or­i­ty re­view ear­li­er that should have sig­ni­fied a more pos­i­tive reg­u­la­to­ry frame of mind. And Athenex was clear that any come­back for this pro­gram is go­ing to face a high bar at the FDA.

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