Investigation
10/05/2021
Initial Lawsuit
10/05/2021
Lawsuit Progression
01/25/2022
Investigation regarding Nano-X’s statements about the approval of its 510(k) application for the Nanox.ARC digital X-ray technology.
08/19/2021
Nano-X reports that it received a request for additional information from the U.S. Food and Drug Administration (FDA) concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC.
“The submission file is placed on hold pending a complete response to the FDA’s list of deficiencies. The Company’s response is due within 180 days from the date of the request for additional information.”
Stock Impact
| Close | Previous close | Price variation | Percentage variation |
|---|---|---|---|
| $21.43 | $23.68 | $-2.25 | -9.5% |
Plaintiff brings this federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Nano-X securities between June 17, 2021 and August 18, 2021, both dates inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:
(i) Nano-X’s 510(k) application for the Nanox.ARC was deficient;
(ii) accordingly, it was unlikely that the FDA would approve the 510(k) application for the Nanox.ARC in its current form;
(iii) as a result, NanoX had overstated the Nanox.ARC’s regulatory and commercial prospects; and
(iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
01/25/2022
The court issued an order appointing the lead plaintiff and lead counsel.