PTE Stock Soars 70% Following PolarityTE’s New FDA Designation
PolarityTE (NASDAQ:PTE) stock is rocketing higher on Friday thanks to positive news from the U.S. Food and Drug Administration (FDA).
The big news here is the FDA granting Regenerative Medicine Advanced Therapy (RMAT) designation for the company’s SkinTE product. SkinTE is an investigational new drug in development to treat chronic cutaneous ulcers.
According to PolarityTE, this new RMAT designation will allow it to move forward with testing of the treatment in clinical trials. It should also speed up the company’s approval process and aid it in manufacturing the product for commercial use.
Richard Hague, CEO of PolarityTE, had the following to say in the news release sending PTE stock higher today.
“FDA granting our request for an RMAT designation for SkinTE validates not only the strength of the preliminary clinical evidence we have developed to date but also demonstrates the seriousness of the conditions that we seek to treat and the substantial nature of the unmet needs among the patient populations that we aim to serve.”
Today’s news brings with it heavy trading of PTE stock. This has some 53 million shares on the move as of this writing. That’s quite the jump over the company’s daily average trading volume of about 6.5 million shares.
PTE stock is up 48% as of Friday morning.
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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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