Business
Humacyte Second Quarter 2024 Financial Results and Business Update
-FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma- -Reported
About this update from Humacyte, Inc.
[{"type":"text","content":"-FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma- -Reported Positive Topline Results from Phase 3 Trial of ATEV in Hemodialysis Access- -ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA in Advanced Peripheral Artery Disease- -Conference call and live webcast at 8:30 a.m. ET today- DURHAM, N.C., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the second quarter ended June 30, 2024 and highlighted recent accomplishments. “We were surprised to be notified by the FDA that they will require additional time to complete their review of the BLA for our ATEV (acellular tissue engineered vessel) in vascular trauma,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “FDA leadership noted that Humacyte’s ATEV is a first-in-class product, and that Priority Review had been granted, which involves only a six-month review cycle, as compared to the standard ten-month review cycle for most products. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma, although we currently do not yet have a revised action date.” “The ATEV continues to make significant progress in its other investigational indications, including in hemodialysis access,” continued Dr. Niklason. “We were pleased to announce positive top-line results from the V007 Phase 3 clinical trial in patients with end-stage renal disease, in which the ATEV was observed to have superior functional patency over current standard of care. In addition, the ATEV received its third RMAT designation from the FDA, specifically in advanced peripheral artery disease. This serves as a recognition from the Agency that Humacyte’s ATEV may provide an important therapeutic option for patients with advanced arterial disease in their legs, who are facing potential amputation. ...