Nano-X Imaging Ltd
|Company Name||Nano-X Imaging Ltd|
|Class Period||June 17, 2021 to August 18, 2021|
|Lead Plaintiff Motion Deadline||December 06, 2021|
On August 19, 2021, Nano-X revealed that it had “received a request for additional information from the U.S. Food and Drug Administration (the ‘FDA’) concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC.” The 510(k) submission was placed on hold pending the Company’s response.
On this news, the Company’s stock price fell $2.25 per share, or 9.5%, to close at $21.43 per share on August 19, 2021, thereby injuring investors.
The complaint filed alleges that throughout the Class Period, 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 failed to disclose to investors that: (1) Nano-X's 510(k) application for the Nanox.ARC was deficient; (2) accordingly, it was unlikely that the FDA would approve the 510(k) application for the Nanox.ARC in its current form; (3) as a result, Nano-X had overstated the Nanox. ARC's regulatory and commercial prospects; and (4) as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.
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