The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ:PTE) SkinTE under the its open investigational new drug application (IND).
PolarityTE has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA), currently pursuing the first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication.
Richard Hague, Chief Executive Officer, commented : ”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.”
Regenerative Medicine Advanced Therapy (RMAT) designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products, including human cellular and tissue-based therapies. The RMAT designation provides the benefits of intensive FDA guidance on efficient drug development.
PolarityTE Shares are trading high 48 percent at $0.22
