Clovis plunges on rociletinib update

Clovis Oncology Inc. (NASDAQ:CLVS) shed $69.19 (70%) to $30.24 on volume of 30.6 million shares Monday after disclosing the rate of confirmed responses to lung cancer compound rociletinib ( CO-1686) was lower than previously reported unconfirmed response rates that served as the primary basis for an NDA submission. Clovis said FDA asked for more clinical data on the molecule and that the agency's review will rely solely on confirmed responses.

The company said it would submit those data on Monday as a major amendment to its NDA and that the process may delay FDA's review timeline beyond rociletinib's PDUFA date of March 30, 2016. ...