WASHINGTON (dpa-AFX) - 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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