
LegalZoom.com, Inc. (LZ)
Whether directors and officers of LegalZoom.com, Inc. (LZ) breached their fiduciary duties to the company and its shareholders.
Investigation
02/08/2022
Initial Lawsuit
02/16/2022
Lawsuit Progression
05/13/2022
Did the company mislead shareholders regarding its communication with the FDA and/or the clinical evidence supported by the IDE study?
The FDA concluded of insufficient clinical evidence to support a 510(k) submission to expand the label for the CellFX System to treat sebaceous hyperplasia, leading the company’s stock price to decrease more than 34 percent that day.
We have opened this page for investors to gather facts, findings and track related lawsuits. We invite investors and shareholders to read the events in the factual timeline below, add any and vote on their pertinence. A lawsuit was subsequently filed. We will update this post as it unfolds.
02/08/2022
Pulse Biosciences discloses the receipt of a letter from the U.S. Food and Drug Administration (FDA) in response to its 510(k) submission to add the specific indication for treatment of sebaceous hyperplasia to expand the CellFX System’s current labeling.
In the letter, the FDA explained it did not believe the company provided sufficient clinical evidence to support the expanded indication for use and that the company had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study.
“The Company anticipates meeting with the FDA to discuss the contents of the AI letter and potential next steps, which may require additional clinical data and potentially a new 510(k) submission.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$7.12 | $10.86 | $-3.74 | -34.44% |
This is a class action on behalf of persons and entities that purchased or otherwise acquired Pulse Biosciences, Inc. securities between January 12, 2021 and February 7, 2022, 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:
(1) that the IDE study evaluating the use of the CellFX System to treat sebaceous hyperplasia lesions failed to meet its primary endpoints;
(2) that, as a result, there was a substantial risk that the FDA would reject Pulse’s 510(k) submission seeking to expand the label for the CellFX System to treat sebaceous hyperplasia lesions; and
(3) that, as a result of the foregoing, defendants’ positive statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
05/13/2022
The court issued an order appointing the lead plaintiff and lead counsel.
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