Humacyte, Inc. 8K

Humacyte reported strong Phase 3 interim results for its ATEV dialysis access product, is ending enrollment in the V012 trial, and plans a supplemental BLA filing with the FDA in 2H 2026, while outlining commercial progress and pipeline developments for its Symvess/ATEV regenerative vascular products.

Humacyte, Inc. furnished an investor presentation describing the company’s FDA‑approved acellular tissue engineered vessel product Symvess for extremity vascular trauma and its broader regenerative medicine platform, highlighting positive interim Phase 3 results from the V012 trial in women with end‑stage kidney disease showing that its bioengineered acellular tissue engineered vessels (ATEVs) for hemodialysis access achieved statistically significant superiority to arteriovenous fistulas in catheter‑free days and reduced access infections, along with previously reported positive V007 Phase 3 data, the decision to terminate further enrollment in V012 per protocol after meeting the primary endpoint, and plans to file a supplemental BLA with the FDA in the second half of 2026 for use of ATEVs in adult ESKD patients at increased risk of AV fistula maturation failure, while also outlining pipeline programs in peripheral arterial disease, CABG, and a BioVascular Pancreas, commercial launch and market opportunity for Symvess, and its manufacturing scale and Department of Defense support.

Filing Facts

CIK

1818382

Ticker

-

Form

8K

Source Type

sec

Accession

0001104659-26-072382

Alert Tier

7