– FDA authorizes extension of Symvess expiration dating from 18 months to 36 months – – Extended shelf life supported by additional stability data demonstrating Symvess continues to meet all established quality specifications throughout the 36-month dating period – DURHAM, N.C., Sept....
– 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...
