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Humacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access Patients

Humacyte (HUMA)HumacyteClinical readout

- Humacyte plans to file a supplemental Biologic License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026 - - The ATEV met V012’s primary endpoint and was observed to have superior catheter-free days (p=0.00070) compared to autologous arteriovenous (AV)

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Humacyte

Bioengineered Human Tissue Platform Humacyte develops implantable vascular conduits manufactured from human vascular cells and designed to become repopulated by the patient's own cells. The platform is intended to produce universally implantable tissues at commercial scale. SYMVESS SYMVESS is an FDA-approved acellular tissue-engineered...

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