Kehoe Law Firm, P.C. is investigating potential claims on behalf of investors of Apyx Medical Corporation (“Apyx”) (NASDAQ: APYX) pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
A class action lawsuit was filed on behalf of individuals or entities that purchased, or otherwise acquired, Apyx Medical Corporation securities between August 1, 2018 and April 1, 2019, inclusive (the “Class Period”).
Investors have 60 days from April 17, 2019 to move the Court to serve as lead plaintiff in the securities class action lawsuit. If you are an APYX shareholder who has suffered losses, please click Join a Securities Class Action to participate in the class action lawsuit or contact John Kehoe, Esq., (215) 792-6676, Ext. 801, [email protected], [email protected].
On February 21, 2019, White Diamond Research released a report alleging that a clinical study on the use of Apyx’s J-Plasma for dermal resurfacing may have missed its endpoints.
On this news, shares of Apyx fell $2.10 per share, or approximately 25%, to close at $6.40 on February 21, 2019, thereby injuring investors.
Subsequently, on April 1, 2019, Apyx announced that it “. . . withdr[ew] its application for premarket notification 510(k) regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures. [Apyx] will continue to work with the U.S. Food and Drug Administration . . . relative to the development of a new 510(k) submission. At the present time, [Apyx] cannot provide a timeline for resubmission but intends to do so after further discussions with the [FDA].”
Apyx stated that although an “investigational device exemption (IDE) study evaluating the safety and efficacy of J-Plasma/Renuvion technology for the reduction of facial wrinkles and rhytides,” did not “. . . yield . . . serious adverse events . . . , the study did not meet the primary efficacy endpoint . . . .” Apyx also stated that “[i]n the course of [FDA] review of . . . [Apyx’s] submission, the [FDA] raised a number of questions and concerns related to superior clinical results from one investigational center as compared to the other two investigational centers in the study. The [FDA] also questioned the potential impact of protocol deviations at this investigational center including the prophylactic use of methylprednisolone in all but five subjects treated.”
On this news, shares of Apyx fell $2.49 per share, or more than 35%, to close at $4.46 on April 2, 2019, thereby further injuring investors.
The class action complaint filed in United States District Court for the Middle District of Florida alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about Apyx’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 Apyx’s application for regulatory clearance; (3) and, as a result, Apyx was unlikely to receive regulatory approval of J-Plasma for dermal resurfacing; and (4) as a result of the foregoing, Defendants’ positive statements about Apyx’s business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis.
Investors who purchased APYX stock during the Class Period and suffered damages have 60 days from April 17, 2019 to seek appointment as lead plaintiff. Again, Apyx investors can click Join a Securities Class Action to participate in the lawsuit. Please note that no class has been certified in the above action, and until a class is certified, you are not represented by counsel unless you retain an attorney of your choice. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may serve together as “lead plaintiff.” Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff.