HUMA biotech catalysts & pipeline

HUMACYTE INC · Data as of 2026-09-08

Upcoming catalysts

ATEV — Supplemental NDA/BLA submission

Nov 2026

DURHAM, N.C. , Aug. 24, 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 recent discussions with the FDA confirm the Company's plans and expectations for filing a supplemental Biologic License Application (BLA) with the FDA for the acellular tissue engineered vessel (ATEV) in dialysis access. Humacyte expects to file the supplemental BLA during November 2026 , seeking to add dialysis access as the second approved indication for the ATEV after its December 2024 FDA approval in the vascular trauma indication.

Source filing

CTEV — Initial data

2026

Anticipated 2026 Milestones Vascular Trauma (Symvess): • U.S. commercial launch growth • Expansion into international markets Dialysis (ATEV): • Publication of V007 Phase 3 results • Interim results from V012 Phase 3 trial in female patients • Supplemental BLA filing with FDA All milestone dates are only management estimates Vascular Trauma - Symvess: • U.S. commercial launch • Long-term results showing durability of Symvess V007 dialysis positive Phase 3 ATEV two-year results Cardiac Bypass Graft Surgery (CABG) CTEV preclinical results from large-animal studies Preclinical BVP results showing survival and function of islets in large animals Completed in 2025 Planned for 2026 CABG (CTEV): • Commencement of first-in-human study • First patient results BioVascular Pancreas (BVP) for type-1 diabetes: • Preparation for first human study Publications & Presentations (Multiple other clinical and preclinical publications and presentations expected for 2026) 54

Source filing

ATEV — Full data

2026

Anticipated 2026 Milestones Vascular Trauma (Symvess): • U.S. commercial launch growth • Expansion into international markets Dialysis (ATEV): • Publication of V007 Phase 3 results • Interim results from V012 Phase 3 trial in female patients • Supplemental BLA filing with FDA All milestone dates are only management estimates Vascular Trauma - Symvess: • U.S. commercial launch • Long-term results showing durability of Symvess V007 dialysis positive Phase 3 ATEV two-year results Cardiac Bypass Graft Surgery (CABG) CTEV preclinical results from large-animal studies Preclinical BVP results showing survival and function of islets in large animals Completed in 2025 Planned for 2026 CABG (CTEV): • Commencement of first-in-human study • First patient results BioVascular Pancreas (BVP) for type-1 diabetes: • Preparation for first human study Publications & Presentations (Multiple other clinical and preclinical publications and presentations expected for 2026) 54

Source filing

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