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Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions

Humacyte (HUMA)HumacyteFDA / regulatory

– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 – – Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women – – The V012 dialysis

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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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308.61M USD
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