Pulse Biosciences, Inc.
|Company Name||Pulse Biosciences, Inc.|
|Class Period||January 12, 2021 to February 07, 2022|
|Lead Plaintiff Motion Deadline||April 18, 2022|
In October 2020, Pulse initiated its investigational device exemption (“IDE”) study to evaluate the treatment of sebaceous hyperplasia lesions using the CellFX System.
On February 8, 2022, before the market opened, Pulse announced that the U.S. Food and Drug Administration (“FDA”) concluded there was insufficient clinical evidence to support the Company’s 510(k) submission to expand the label for the CellFX System to treat sebaceous hyperplasia. Among other things, the FDA found “that the Company had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study.”
On this news, the Company’s share price fell $3.74, or over 34%, to close at $7.12 per share on February 8, 2022, on unusually heavy trading volume.
The complaint filed in this class action 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: (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.
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