All investors who purchased PolarityTE, Inc. and incurred losses are urged to contact the firm immediately at email@example.com or (800) 575-0735 or (212) 545-4774. You may obtain additional information concerning the action or join the case on our website, www.whafh.com.
If you have incurred losses in the shares of PolarityTE, Inc., you may, no later than November 23, 2021, request that the Court appoint you lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights as an investor in PolarityTE, Inc.
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.
Subsequently, 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, PolarityTE’s stock price fell $0.08 per share, or 9.52%, to close at $0.76 per share on August 24, 2021.
Wolf Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.
If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735, via e-mail at firstname.lastname@example.org, or visit our website at www.whafh.com.
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