Shares in Endologix, Inc. (NASDAQ:ELGX), which makes minimally invasive treatments for aortic disorders, tanked Wednesday after the company revealed that the FDA wanted more data for its Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System).
The stock ended Wednesday at $7.82, down 20.53%, on volume of 12.31 million shares – over 11X its average volume.
Technically, on the long term monthly chart, the stock is inexorably making lower highs and lower lows.
Yesterday’s slide tested the previous bottom of $6.51 of February 2016, though not on a closing basis.
Endologix, Inc. (NASDAQ:ELGX) may be forced to delay Nellix by a year
The U.S Food and Drug Administration (FDA) has asked the Company to provide 2-year patient follow-up data from the EVAS-FORWARD IDE Study of the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System). Nellix is an investigational device in the United States.
The result of the FDA action is that approval for Nellix now stands deferred by at least a year – that’s because the data can be submitted only by the second quarter of 2017, with an advisory panel meeting likely by end-2017, and approval in the second quarter of 2018.
“We’re disappointed by these requirements and the resulting delay, but encouraged by the 2-year clinical outcomes we have seen so far with Nellix under our newly revised instructions for use,” said John McDermott, Chief Executive Officer. “We remain committed to EVAS with Nellix and have demonstrated outstanding clinical results in selected patients with both traditional and complex AAA anatomies.”
Endologix, Inc. (NASDAQ:ELGX): potential class action suit
Rosen Law Firm, a global investor rights law firm, is preparing a class action suit against Endologix for allegedly issuing misleading information regarding Nellix to investors, and who suffered losses on their investments due to the fall in their value consequent to the FDA request for more data.
Analysts at JP Morgan yesterday downgraded Endologix from Overweight to Neutral.