Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –
NEW YORK and NEW ORLEANS, Aug. 21, 2026 /PRNewswire/ -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq.
– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes –
Denali Therapeutics (NASDAQ: DNLI - Get Free Report) and Humacyte (NASDAQ: HUMA - Get Free Report) are both healthcare companies, but which is the superior stock? We will compare the two businesses based on the strength of their analyst recommendations, dividends, valuation, institutional ownership, earnings, profitability and risk. Analyst Recommendations This is a summary of recent recommendations
– 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 –
Humacyte, Inc. (HUMA) Q2 2026 Earnings Call Transcript
Humacyte, Inc. (HUMA) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.1. This compares to a loss of $0.24 per share a year ago.
Humacyte NASDAQ: HUMA reported second-quarter commercial sales growth while outlining plans to expand adoption of its SYMVESS vascular repair product, submit a supplemental biologics license application for dialysis access and begin a first-in-human coronary bypass study.
– 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 –
NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into Humacyte, Inc. (NasdaqGS: HUMA) (“Humacyte” or the “Company”). On August 9, 2024, the company announced that the Food and Drug Administration (“FDA”) “will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engin.
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 months and six months ended June 30, 2026, on Wednesday, August 12, 2026. Management will host a webcast and conference call at 8:00 a.m. Eastern Time to provide a corporate and financial update.
Humacyte, Inc. (HUMA) concluded the recent trading session at $0.73, signifying a +2.33% move from its prior day's close.
Humacyte, Inc. (HUMA) concluded the recent trading session at $0.63, signifying a -6.44% move from its prior day's close.
– 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 NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that the Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of the coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG).
In the latest trading session, Humacyte, Inc. (HUMA) closed at $0.67, marking a +2.22% move from the previous day.
Humacyte, Inc. (HUMA) closed at $0.66 in the latest trading session, marking a -1.28% move from the prior day.
Humacyte, Inc. (HUMA) closed the most recent trading day at $0.71, moving +2.31% from the previous trading session.
- 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 -
The latest trading day saw Humacyte, Inc. (HUMA) settling at $0.78, representing a -2.32% change from its previous close.
Humacyte, Inc. (HUMA) concluded the recent trading session at $0.62, signifying a -11.14% move from its prior day's close.