was soaring in pre-market trading on reports the FDA might not require it to conduct a large clinical trial on its Erbitux cancer treatment.
Published reports said the FDA, which met Tuesday with Imclone and partner
, would be willing to consider an Erbitux application that was updated with results of European clinical trial data.
The FDA said in December it wouldn't accept the application as currently constituted, prompting a sell-off in the biotech firm's shares that had cut their value by 70%.
, ImClone must compile new documentation from its raw data and have it analyzed by an independent review council which would determine the extent to which Erbitux is effective, the source said. The FDA recommended that ImClone include in its renewed submission data from clinical trials of Erbitux being conducted in Europe by Germany's
, which holds the rights to market Erbitux outside the U.S.
On Instinet, Imclone's shares were up $7.48, or 48%, to $23.