PolarityTE, Inc.

  • Active

Investigation
09/24/2021

Initial Lawsuit
09/24/2021

Lawsuit Progression
12/20/2021

Investigation

  • Continous Holding
    April 30, 2020 to August 23, 2021
  • Proposed Claim
    Securities Violation

Investigation regarding PolarityTE’s statements about its investigational new drug application for SkinTE and related chemistry, manufacturing and control items.

Main Event

CMC Problems

08/24/2021

Company Statement

PolarityTE announces that the U.S. Food and Drug Administration (FDA) provided feedback, related to its Investigational New Drug Application (IND) for SkinTE, that certain Chemistry, Manufacturing, and Control (CMC) 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.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$0.76 $0.84 $-0.08 -9.52%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 09/24/2021

Plaintiff brings this securities class action on behalf of a class consisting of all persons other than Defendants who purchased or otherwise acquired PolarityTE securities between April 30, 2020 and August 23, 2021, both dates inclusive.

  • Filing Date
    09/24/2021
  • Class Period
    04/30/2020 to 08/23/2021
  • Transgression
    Securities Violation
  • Filing Firms
    Pomerantz LLP
    Harper Law, PLC
  • Case Title
    Richfield v. Polarityte et al
  • Docket Number
    2:21-cv-00561
  • Court
    Utah District Court
  • Free File
    Complaint

Allegations

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 that:

(i) the SkinTEIND 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.

Defendants

  • Company
    PolarityTE, Inc.
  • Chief Executive Officer
    David B. Seaburg
  • Chief Financial Officer
    Jacob Alexander Patterson
  • Chief (Other)
    Richard Hague

Lawsuit progression

  • Docket Number
    2:21-cv-00561
  • Court
    Utah District Court

Lead Counsel

12/20/2021

The court issued an order appointing the lead plaintiff and lead counsel.

  • Lead Counsel
    The Rosen Law Firm, P.A.
  • Lead Plaintiff
    Individual
  • Free File
    Order for lead

Amended Complaint

02/21/2022

This is a federal securities class action on behalf of a class of all person and entities other than defendants that purchased or otherwise acquired PolarityTE common stock between January 30, 2018 and November 9, 2021, both dates inclusive.

  • Updated Class Period
    01/30/2018 to 11/09/2021
  • Free File
    Amended Complaint

    • Operative complaint

[stockdio-historical-chart symbol=”PTE” stockExchange=”NYSENasdaq” width=”500″ height=”330″ motif=”blinds” palette=”humanity” includeVolume=false]

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