By Dean Seal


Shares of Humacyte gained after the company said regulators have granted a special advanced-therapy designation to its implant for vascular replacement and repair.

The stock was up 10% at $5.27 in premarket trading. Shares had already gained 69% year-to-date when the market closed last week.

The clinical-stage biotechnology company said on Monday morning that the Food and Drug Administration has granted a Regenerative Medicine Advanced Therapy designation to its Acellular Tissue Engineered Vessel, or ATEV, for patients with advanced peripheral artery disease, a cardiovascular disease of blood vessels that affects arteries, typically in the legs.

ATEV is designed to be an implantable vascular conduit for use in vascular replacement and repair, Humacyte said.

The designation is designed to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. It should also allow for close interactions with the FDA and, potentially, a priority review of biologics license applications, the company said.

Humacyte said the designation comes in tandem with the FDA clearing an investigational new drug application for ATEV with an indication for patients with advanced peripheral artery disease.

The FDA previously granted the special status to ATEV for vascular trauma repair and arteriovenous access in hemodialysis.

"We are very pleased to receive our third RMAT designation from the Food and Drug Administration," the company said.


Write to Dean Seal at dean.seal@wsj.com


(END) Dow Jones Newswires

07-01-24 0927ET