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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