Endologix Sees FDA Approval Of Nellix Remaining Elusive; BMO Downgrades

BMO Capital Markets has downgraded Endologix, Inc. ELGX to Market Perform from Outperform after FDA’s request of two-year follow-up data from Nellix clinical study, instead of a one-year follow-up. The news sent the company's shares in to a tailspin.

The Nellix Issue

The Nellix EVAS System is the company's investigational device to seal the entire abdominal aortic aneurysm sac developed to reduce all types of endoleaks and improve long-term patient outcomes.

The submission of additional data would delay the potential FDA approval to second quarter of 2018 from third quarter of 2017.

“While we have a high level of confidence that Nellix is an approvable device, we have a very low level of confidence in the timing,” analyst Joanne Wuensch wrote in a note.

Analyst's Take

The analyst also cut 2017 revenue forecast to $216 million from $217 million and 2018 estimate to $246 million from $259 million. Wuensch also trimmed the price target to $9.50 from $14.

“While we do expect additional information at the Thursday VEITH Analyst meeting, baring something unforeseen, we believe in the relative near term it will be tough for the stock to Outperform,” Wuensch added.

At last check, shares of Endologix had fallen 6.14 percent to $7.34.