Humacyte, Inc. HUMA
Humacyte, Inc. (Nasdaq: HUMA) is a cardio-renal-metabolic drug developer. Its lead program, Symvess (acellular tissue engineered vessel, ATEV), is in Phase 3 for vascular trauma; AV access for hemodialysis (supplemental BLA planned).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Symvess (ATEV) | extremity vascular trauma | biologic-other | Approved |
| ATEV | AV access for hemodialysis (supplemental BLA planned) | biologic-other | Phase 3 |
Recent results and decisions
- Aug 12, 2026accepted FDA accepted IND for first-in-human CTEV study in CABG.
We are also pleased that the FDA recently accepted our Investigational New Drug (IND) application for our coronary tissue engineered vessel (CTEV), and plan to initiate a Phase 2a study in coronary artery bypass grafting (CABG) during the third quarter.
Filing - Jun 10, 2026met V012 Phase 3 interim analysis (first 80 patients) met superiority primary endpoint: 220 vs 129 catheter-free days for ATEV vs AV fistula (+91 days, p=0.00070); infections 6 vs 23 per 100 patient-years.
In a prespecified interim analysis conducted in the first 80 patients enrolled in the study, the V012 trial’s primary endpoint was met with the ATEV observed to have an average of 91 more catheter-free days compared to autologous arteriovenous (AV) fistula, the current standard of care.
Filing - Nov 12, 2025positive Two-year V007 Phase 3 results presented at Kidney Week: ATEV had superior duration of use over 24 months vs autogenous fistula in high-need subgroups.
The ATEV was observed to have superior duration of use over 24 months compared to autogenous fistula in high-need subgroups having historically poor outcomes with arteriovenous (AV) fistula procedures.
Filing
For subscribers
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Other phase 3 cardio-renal-metabolic companies
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