– 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...
– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes – – Publication provides peer-reviewed validation for V007 Phase 3 data, and complements recent release of Phase 3 V012 data showing ATEV outperformed...
– Jeromy Brink, MD, Mayo Clinic–trained vascular surgeon in Phoenix, is the first surgeon in Arizona to implant Symvess, the first and only FDA-approved bioengineered human blood vessel – – Symvess is available off-the-shelf in the operating room, sparing surgeons the time required to harvest a...
– Breakthrough results from V012 dialysis access Phase 3 study, where ATEV was observed to outperform AV fistula; supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug Administration ( FDA) during the second half of 2026 – – FDA accepted IND for...
DURHAM, N.C., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the Company will release its financial results for the three...
– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter – – Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific meetings and in a recent publication – DURHAM, N.C., July 27, 2026 (GLOBE...
- Dr. Robert J. Kossmann has served as a prominent advocate for kidney disease patients in multiple roles including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America - - Dr. Prabir Roy-Chaudhury is the Immediate Past President of the American Society of...
– Positive results from the V012 Phase 3 study were presented at the Society for Vascular Surgery's Vascular Annual Meeting in Boston – – Women who received Humacyte's ATEV experienced an average of three more months without a dialysis catheter than women who received AV fistula, the current...
DURHAM, N.C., June 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the pricing of an underwritten public offering of 47,619,048 shares...
DURHAM, N.C., June 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has commenced an underwritten public offering of its common...
