Humacyte's Bioengineered Blood Vessel Hits Primary Endpoint in Phase 3 Trial

By Kelly Cloonan

Humacyte's bioengineered human blood vessel met its primary endpoint for dialysis access in a recent Phase 3 trial.

The commercial-stage biotechnology platform company's acellular tissue engineered vessel had an average of 91 more catheter-free days compared to autologous arteriovenous fistula, the current standard of care, in the first 80 patients enrolled in the study.

The study will now end enrollment and continue to follow existing patients, in accordance with its protocol after meeting the primary endpoint, the company said Wednesday.

Humacyte expects to file a supplemental biologic license application with the Food and Drug Administration in the second half. It currently plans to target an indication focused on adult patients with end-stage kidney disease who are at increased risk of AVfistula maturation failure, the company said.

Separately, Humacyte also said it has commenced an underwritten public offering of its common stock. The number of shares it plans to sell wasn't disclosed.

The company will grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the offering.

Humacyte plans to use the proceeds from the offering to fund the commercialization of Symvess, for the planned filing of a BLA supplement in a hemodialysis indication and to develop product candidates in its pipeline.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

June 10, 2026 17:17 ET (21:17 GMT)