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Humacyte (NASDAQ:HUMA) stock rallied 19% Monday on news that the company has received FDA regenerative medicine advanced therapy, or RMAT, designation for its product candidate Acellular Tissue Engineered Vessel, or ATEV, for the treatment of peripheral artery disease.
The biotech company noted it was the third RMAT designation for the product, formerly known as Human Acellular Vessel. The product also has RMAT designations for vascular trauma repair and arteriovenous access in hemodialysis.
The FDA also cleared the company’s application to begin clinical testing of the product for peripheral artery disease.