Humacyte (HUMA) said Monday it plans to file in November a supplemental biologics license application with the US Food and Drug Administration to seek approval for the use of its acellular tissue engineered vessel in dialysis access.

The company said it will support the filing with data from three phase 3 trials, including a study where female dialysis patients averaged three additional months without a catheter compared with standard of care.

The product received regulatory approval in December 2024 for vascular trauma, Humacyte said.

Shares of the company were up 6.4% in Monday premarket activity.