PolarityTE, Inc. (PTE)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of PolarityTE, Inc. (“PolarityTE” or the “Company”) (NASDAQ: PTE). The investigation concerns whether PolarityTE and certain of its officers and/or directors have violated federal securities laws.
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 (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 sharply during intraday trading on August 24, 2021.
If you are aware of any facts relating to this investigation, or purchased PolarityTE shares, you can assist this investigation. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.