NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against PolarityTE, Inc. (“PolarityTE” or the “Company”) (NASDAQ: PTE) in the United States District Court for the District of Utah on behalf of all persons and entities who purchased or otherwise acquired PolarityTE securities between April 30, 2020 and August 23, 2021, both dates inclusive (the “Class Period”). Investors have until November 23, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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On April 30, 2020, PolarityTE issued a press release announcing that the Company had decided to pursue a plan to submit an Investigational New Drug Application (“IND”) and thereafter a Biologics License Application to the U.S. Food and Drug Administration (“FDA”) for SkinTE.
On July 23, 2021, PolarityTE submitted an IND to the FDA seeking authorization to commence a clinical trial to evaluate SkinTE for the proposed indication of treatment of chronic cutaneous ulcers (the “SkinTE IND”).
On August 24, 2021, PolarityTE issued a press release “provid[ing] an update regarding correspondence from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) for SkinTE® with a proposed indication for chronic cutaneous ulcers, which was filed on July 23, 2021. The FDA provided feedback that certain Chemistry, Manufacturing, and Control items need to be addressed prior to proceeding with a pivotal study. As a result, the study proposed in the IND has been placed on clinical hold. In accordance with standard practice and regulations, the FDA has advised that it will issue a clinical hold letter providing details on the basis for the hold to the Company by September 21, 2021.”
On this news, PolarityTE’s stock price fell $0.08 per share, or 9.52%, to close at $0.76 per share on August 24, 2021.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the SkinTE IND was deficient with respect to certain Chemistry, Manufacturing, and Control items; (ii) as a result, it was unlikely that the FDA would approve the SkinTE IND in its current form; (iii) accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
If you purchased or otherwise acquired PolarityTE shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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