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Apyx Medical Corporation

Company NameApyx Medical Corporation
Stock SymbolAPYX
Class PeriodAugust 01, 2018 to April 01, 2019
Lead Plaintiff Motion DeadlineJune 17, 2019

On February 21, 2019, White Diamond Research released a report alleging that a clinical study on the use of the Company’s J-Plasma for dermal resurfacing may have missed its endpoints.

On this news, shares of Apyx fell $2.10 per share, or nearly 25%, to close at $6.40 on February 21, 2019, thereby injuring investors.

Then, on April 1, 2019, Apyx announced that it had withdrawn its 510(k) application for the use of J-Plasma for dermal resurfacing, citing concerns raised by the FDA. Apyx revealed that the FDA had questioned the device’s clinical results, which differed greatly from two of the investigational centers used in the study, as well as the potential impact certain protocol deviations. Moreover, Apyx disclosed that the clinical study did not meet its primary efficacy endpoint.

On this news, shares of Apyx fell $2.49 per share, or over 35%, to close at $4.46 on April 2, 2019, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose: (1) that the clinical study on the use of J-Plasma for dermal resurfacing had not met its primary efficacy endpoint; (2) that, as a result, the clinical study did not support the Company’s application for regulatory clearance; (3) that, as a result, the Company was unlikely to receive regulatory approval of J-Plasma for dermal resurfacing; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis.

 

 

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