SALT LAKE CITY, Feb. 26, 2024 (GLOBE NEWSWIRE) -- PolarityTE today announced the Screening of the first subject in the Phase III pivotal study evaluating SkinTE in the investigational treatment of...
SALT LAKE CITY, Nov. 9, 2022 /PRNewswire/ --PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, today confirmed that on November 1, 2022, it received an unsolicited, non-binding offer (followed by an amended offer on November 8, 2022) from Michael Brauser to acquire all of the outstanding common stock of the Company not owned by him for $1.25 per share in cash. The offer is subject to various contingencies, including, among others, (1) settlement with warrant holders and satisfactory negotiations with insiders with change of control agreements, (2) minimum tender conditions, (3) a sixty-day due diligence period, and (4) satisfaction of other conditions and requirements that may arise, which are commonplace in transactions of this nature.
PolarityTE Reports Q2 2022 Rusult and Provides Business Update
PolarityTE, Inc. (Nasdaq: PTE) a biotechnology company developing regenerative tissue products and biomaterials, today provided a business update and ...
SALT LAKE CITY, May 13, 2022 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE) today announced that the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company's open IND.
SALT LAKE CITY, Dec. 20, 2021 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE) a biotechnology company developing regenerative tissue products and biomaterials, today announced that it has submitted its complete response to the U.S. Food and Drug Administration's (FDA) clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE® with a proposed indication for chronic cutaneous ulcers. As previously disclosed, the primary hold issues are certain Chemistry, Manufacturing, and Control (CMC) items, including the assay to demonstrate the potency of SkinTE.
SALT LAKE CITY, Oct. 7, 2021 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE) a biotechnology company developing regenerative tissue products and biomaterials, today provided an update regarding its Investigational New Drug Application (IND) for SkinTE® with a proposed indication for chronic cutaneous ulcers submitted to the Food and Drug Administration (FDA) in July 2021.
PolarityTE (NASDAQ:PTE) announces the appointment of Richard Hague as the company's chief executive officer and Ryan Mathis as its chief medical officer.
PolarityTE's submission for regenerative therapy SkinTE has been put on hold by the FDA because of chemistry, manufacturing and control concerns.
SALT LAKE CITY--(BUSINESS WIRE)--PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, today provided 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.