---
schema_version: "secwatch.filing_event.v1"
accession: "0001818382-24-000005"
form_type: "8-K"
ticker: "HUMA"
cik: "0001818382"
company_name: "Humacyte, Inc."
filed_at: "2024-02-09T23:59:59+00:00"
generated_at: "2026-06-06T04:56:52.325442+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA grants Priority Review to Humacyte's HAV BLA; PDUFA date August 10, 2024

## Summary
- BLA for Human Acellular Vessel in urgent arterial repair after extremity vascular trauma accepted with Priority Review.
- PDUFA action date set for August 10, 2024; six-month review vs. standard ten months.
- Supporting data from Phase 2/3 V005 trial and real-world use in Ukraine wartime injuries.
- HAV showed higher patency, lower amputation and infection rates versus historic synthetic graft benchmarks.
- Priority Review aligns with prior RMAT designation and DoD priority designation under Public Law 115-92.

## SEC filing metadata
- accession: 0001818382-24-000005
- form_type: 8-K
- ticker: HUMA
- cik: 0001818382
- company_name: Humacyte, Inc.
- filed_at: 2024-02-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818382/000181838224000005/0001818382-24-000005-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818382/000181838224000005/huma-20240209.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001818382-24-000005
- JSON: https://secwatch.observer/filing/0001818382-24-000005.json
- Plain text: https://secwatch.observer/filing/0001818382-24-000005.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.