The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of Utah on behalf of those who acquired PolarityTE, Inc. (“PolarityTE” or the “Company”) (NASDAQ: PTE) securities from April 30, 2020 through August 23, 2021, inclusive (the “Class Period”). Investors have until November 23, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
PolarityTE, a biotechnology company, develops and commercializes a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering, and material sciences in the United States. The Company operates through two segments, Regenerative Medicine Products and Contract Services. It offers SkinTE, a tissue product used to repair, reconstruct, replace, and supplement skin in patients for the treatment of acute or chronic wounds, burns, surgical reconstruction events, scar revision, or removal of dysfunctional skin grafts, as well as contract research services.
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, the Company’s share price declined by $0.08 per share, or approximately 9.52%, from $0.84 per share to close at $0.76 per share on August 24, 2021.
The lawsuit alleges 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 securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at firstname.lastname@example.org, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.