Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against PolarityTE, Inc. (PTE)
The FDA provided feedback that certain Chemistry, Manufacturing, and Control items need to be addressed prior to proceeding with a pivotal study.
NEW YORK, Sept. 27, 2021 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against PolarityTE, Inc. (“Polarity” or the “Company”) (NASDAQ: PTE) in the United States District Court for the District of Utah on behalf of those who purchased PolarityTE securities between April 30, 2020 and August 23, 2021, both dates inclusive (the “Class Period”).
The Complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (1) the SkinTE IND was deficient with respect to certain Chemistry, Manufacturing, and Control items; (2) as a result, it was unlikely that the FDA would approve the SkinTE IND in its current form; (3) accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (4) as a result, the Company’s public statements were materially false and misleading at all relevant times.
On August 24, 2021, the Company 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 stock price fell $0.08 per share, or 9.52%, to close at $0.76 per share on August 24, 2021.
Investors who purchased or otherwise acquired shares of PolarityTE should contact the Firm prior to the November 23, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected].
Please visit our website at http://www.gme-law.com for more information about the firm.
