NEW YORK, October 25, 2021 / PRNewswire / – Pomerantz LLP announces that a class action lawsuit has been filed against PolarityTE, Inc. (“PolarityTE” or the “Company”) (NASDAQ: PTE) and some of its officers. The class action filed in The United States District Court for the district Utah, and registered under 21-cv-00561, is on behalf of a class consisting of all natural and legal persons other than the defendant, the PolarityTE securities between. bought or otherwise acquired April 30, 2020 and 23 August 2021, both dates including (the “Classification Period”) to compensate for damages caused by Defendants’ breaches of federal securities laws and to seek redress under Sections 10 (b) and 20 (a) of the Securities Exchange Act of 1934 (the “Bill of Exchange Act”) and rule 10b-5 against the company and certain of its top officials.
For over 85 years in the fight for victims of securities fraud (PRNewsfoto / Pomerantz LLP)
If you are a shareholder who has purchased PolarityTE securities during the Class Action Period, you will have until November 23, 2021 ask the court to appoint you as the lead plaintiff for the class action. A copy of the complaint is available at www.pomerantzlaw.com. To discuss this action, please contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, extension. 7980. Inquiries by email are encouraged to include their postal address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
PolarityTE, a biotechnology company, develops and markets a variety of regenerative tissue products and biomaterials for the medical, biomedical and materials science sectors in the United States. The company operates in two segments, regenerative medical devices and contract services. It offers SkinTE, a tissue product used to repair, reconstruct, replace and supplement the skin of patients for the treatment of acute or chronic wounds, burns, surgical reconstruction events, scar corrections or removal of dysfunctional skin grafts, and contract research services.
The story goes on
on April 30, 2020PolarityTE published a press release announcing that the company has decided to submit a plan to submit a new drug (“IND”) and then a biologics submission to the US Food and Drug Administration (“FDA “) for SkinTE to track.
on July 23, 2021, PolarityTE has filed an IND with the FDA to apply for approval to begin a clinical trial evaluating SkinTE for the proposed indication for the treatment of chronic skin ulcers (the “SkinTE-IND”).
The lawsuit alleges that during the class action period, defendants made essentially false and misleading statements about the company’s business, operational, and compliance policies. In particular, the Defendants made false and / or misleading statements and / or failed to disclose that: (i) the SkinTE IND was defective in relation to certain chemical, manufacturing and control items; (ii) it was therefore unlikely that the FDA would approve the SkinTE IND in its current form; (iii) accordingly, the Company had significantly overestimated the likelihood that SkinTE IND would receive FDA approval; and (iv) as a result, the Company’s public statements at all relevant times have been materially false and misleading.
on August 24, 2021, PolarityTE published a press release “Provided”[ing] An update on correspondence from the U.S. Food and Drug Administration (FDA) in connection with its Investigational New Drug Application (IND) for SkinTE® with a proposed indication for chronic skin ulcers, which was published on was submitted July 23, 2021. The FDA provided feedback that certain chemical, manufacturing, and control elements must be addressed prior to conducting a pivotal study. As a result, the study proposed in the IND has been clinically put on hold. In accordance with standard practice and regulations, the FDA has notified the company by September 21, 2021. “
As a result of this news, PolarityTE’s share price fell $ 0.08 per share, or 9.52% to close on $ 0.76 per share August 24, 2021.
Pomerantz LLP, with offices in new York, Chicago, The angel, Paris, and Tel Aviv, is recognized as one of the leading law firms in corporate, securities and antitrust litigation. Founded by the late Abraham L. PomerantzKnown as the Dean of the Class Action Chamber, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he founded and fights for the rights of victims of securities fraud, breaches of duty of loyalty and corporate misconduct. The company has collected numerous millions of dollars in damages on behalf of class members. See www.pomlaw.com.
CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980
Cision
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SOURCE Pomerantz LLP










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