PolarityTE (NASDAQ:PTE) stock is taking a beating on Tuesday after the biotechnology company got an update from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug Application (IND).
According to the FDA’s response, PolarityTE isn’t cleared to move forward with a pivotal study of SkinTE. This is the company’s regenerative tissue product for chronic cutaneous ulcers. The FDA says additional Chemistry, Manufacturing, and Control (CMC) items need addressing first.
Following this news, the IND for SkinTE has been placed on clinical hold. The FDA has until Sept. 21, 2021, to provide PolarityTE with a response letter detailing the reason behind this clinical hold.
David Seaburg, CEO of PolarityTE, said this about the news rocking PTE stock today.
“We are actively working to address the issues identified by the FDA and our team plans to respond to the Agency’s feedback as expeditiously as possible, and we are hopeful that we will be able to resolve any open items. Chronic cutaneous ulcers represent a substantial unmet medical need with significant economic burden, and we are grateful for FDA’s engagement and eager to advance SkinTE through clinical studies and the regulatory process towards an eventual BLA submission.”
PTE stock is seeing heavy trading today following this news. As of this writing, more than 4 million shares of the stock have changed hands. That’s a hefty increase over its daily average trading volume of about 1.1 million shares.
PTE stock was down 10.4% as of Tuesday afternoon.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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