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PolarityTE: FDA Grants RMAT Designation For SkinTE

PolarityTE, Inc. (PTE) announced the FDA granted a Regenerative Medicine Advanced Therapy designation to SkinTE. RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products.

Richard Hague, CEO, said: "The Agency has offered—and we look forward to capitalizing upon—a multidisciplinary, comprehensive discussion between PolarityTE and the FDA regarding the SkinTE development program, including planned clinical trials and plans for expediting the manufacturing development strategy."

Shares of PolarityTE were up 92% in pre-market trade on Friday.

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