Endologix faces shareholder suit over Nellix snafu

Endologix (NSDQ:ELGX) is facing a lawsuit from stockholders alleging the company miscommunicated and failed to disclose issues related to its Nellix EVAS stent graft designed for treating abdominal aortic aneurysms.

The shareholders filed the suit in the US District Court for the Central District of California, representing individuals who purchased shares between Aug. 2, 2016 and Nov. 16, 2016, according to an SEC filing.

The suing shareholders allege that the company made “materially false and misleading statements and failed to disclose material adverse facts about its business, operational and financial performance in violation of federal securities laws, relating to FDA PMA for the Company’s Nellix EVAS System,” according to the filing.

Irvine, Calif.-based Endologix said it believes the lawsuits are without merit and it plans to defend itself vigorously, according ot the filing.

Last November, Endologix saw shares drop nearly 25% after the company said the FDA asked for more data on its Nellix stent graft.

The company said the federal safety watchdog wants 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of 2017, pushes potential pre-market approval from the FDA back to the 2nd quarter of 2018, Endologix said.

Investors reacted by pushing ELGX shares down -24.5% to $7.43 apiece in mid-morning trading on Nov. 16.

Endologix won CE Mark approval in the European Union for Nellix back in 2012, less than 2 years after acquiring its namesake company in an all-stock transaction.

 

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