
The U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy designation to PolarityTE's (NASDAQ:PTE) SkinTE under the company's open investigational new drug application (IND).
The company noted that it's IND is open with the FDA and it is pursuing the first of two studies on SkinTE needed to support a biologics license application (BLA) for use of the therapy to treat chronic cutaneous ulcer.
PTE +70.38% to $0.25 premarket May 13