Humacyte plans November FDA filing for dialysis access use

Durham, N.C. - Humacyte Inc., a biotech company trading under the ticker HUMA, has announced its plans to submit a supplemental Biologics License Application to the FDA in November 2026. The filing aims to expand the approved use of its acellular tissue engineered vessel, the ATEV, to include dialysis access, following its approval in December 2024 for vascular trauma treatment.

The FDA discussions confirmed the company's intention to file. Investors can find comprehensive data on Humacyte’s progress through InvestingPro, which provides data on biotech companies navigating the regulatory landscape. The supplemental BLA will rely on data from three Phase 3 studies. The V012 study, which focused on the ATEV for dialysis access, found that women who received the ATEV had an average of three more months without a dialysis catheter compared to those who received a traditional arteriovenous fistula, the standard treatment.

The filing will also include results from the V007 and V006 studies, two completed Phase 3 trials involving male and female dialysis access patients. The V012 Phase 3 trial's top-line interim results were presented at the Society of Vascular Surgery’s Vascular Annual Meeting in June 2026. According to Laura Niklason, Humacyte's founder, president, and CEO, ongoing discussions with the FDA, which included sharing clinical results and the company's filing strategy, have strengthened their confidence in the regulatory pathway for the ATEV in dialysis access.

For indications other than the FDA-approved use for vascular trauma, the ATEV remains an investigational product and has not been approved for commercial sale by the FDA or any other regulatory body. Humacyte's 6mm ATEV for arteriovenous access in hemodialysis has received both the FDA's Regenerative Medicine Advanced Therapy designation and the FDA Fast Track designation.