PolarityTE, Inc. Class Action Lawsuit - PTE

Company Name
PolarityTE, Inc.
Stock Symbol
Class Period
April 30, 2020 to August 23, 2021
Motion Deadline
November 23, 2021
District of Utah
37 days left to seek lead plaintiff status

Case Summary

The PolarityTE class action lawsuit seeks to represent purchasers of PolarityTE, Inc. (NASDAQ: PTE) securities between April 30, 2020 and August 23, 2021, inclusive (the “Class Period”) and charges PolarityTE and certain of its top executives with violations of the Securities Exchange Act of 1934.  The PolarityTE class action lawsuit was commenced on September 24, 2021 in the District of Utah and is captioned Richfield v. PolarityTE, Inc., No. 21-cv-00561.

If you wish to serve as lead plaintiff of the PolarityTE class action lawsuit, please provide your information by clicking here.  You can also contact attorney Michael Albert of Robbins Geller by calling 800/449-4900 or via e-mail at malbert@rgrdlaw.com.  Lead plaintiff motions for the PolarityTE class action lawsuit must be filed with the court no later than November 23, 2021.

CASE ALLEGATIONS: On April 30, 2020, PolarityTE announced that PolarityTE 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”).

The PolarityTE class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and 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, PolarityTE had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (iv) thus, PolarityTE’s public statements were materially false and misleading at all relevant times.

On August 24, 2021, PolarityTE issued a press release regarding its SkinTE IND stating that “[t]he FDA provided feedback 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.”  On this news, PolarityTE’s stock price fell nearly 10%, damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased PolarityTE securities during the Class Period to seek appointment as lead plaintiff in the PolarityTE class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the PolarityTE class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the PolarityTE class action lawsuit.  An investor’s ability to share in any potential future recovery of the PolarityTE class action lawsuit is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions.  Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.  The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm.

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