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Humacyte Inc

Humacyte, Inc. develops and manufactures off-the-shelf, implantable, bioengineered human tissues for treating diseases across multiple therapeutic areas and anatomic locations. Using its proprietary technology platform, the company engineers human acellular vessels (HAVs) designed to be implanted without inducing a foreign body response or immune rejection. Its HAV portfolio targets markets such as vascular trauma, arteriovenous access for hemodialysis, peripheral arterial disease, pediatric heart surgery, and coronary artery bypass grafting, as well as cellular therapy delivery including pancreatic islet cell transplantation for Type 1 diabetes. Founded in 2004, Humacyte is headquartered in Durham, North Carolina.

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Biotech & Genomic Medicine2

Humacyte shares fall after Q2 revenue, EPS miss

Humacyte shares fell 15% after the biotechnology company reported a wider-than-expected second-quarter loss and revenue below estimates. GAAP loss per share was $0.16, missing consensus by 6 cents, while revenue of $0.41 million fell $0.7 million short of expectations. The company said it is rebuilding its commercial effort for Symvess, with initiatives aimed at increasing hospital adoption and product usage, and noted stronger utilization at influential hospitals entering the second half of 2026. Humacyte also highlighted interim Phase 3 results for its acellular tissue-engineered vessel in female dialysis patients, saying the product outperformed autologous arteriovenous fistula, and plans to file a supplemental BLA with the FDA later this year. The FDA recently accepted the company's IND application for its coronary tissue-engineered vessel, with a Phase 2a study in coronary artery bypass grafting planned for the third quarter. Humacyte raised $57.5 million in gross proceeds through a public offering in June and expects workforce and operating cost reductions to generate about $14.3 million in savings during 2026.
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Biotech & Genomic Medicine

Humacyte Wins FDA IND Clearance for First-in-Human Coronary Bypass Trial

Humacyte announced that the FDA has accepted its Investigational New Drug application for the first-in-human clinical study of its Coronary Tissue Engineered Vessel in patients undergoing coronary artery bypass grafting. The Phase 2a trial is expected to begin in the current quarter and will enroll 10 adult CABG patients, evaluating safety and feasibility of the bioengineered vessel as a coronary bypass graft. The study will assess patency through the vessel for two months after implant, with up to three years of follow-up. Humacyte shares are trading up 4.31% at $0.651.
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