other material
confidence high
sentiment neutral
materiality 0.65
Humacyte completes enrollment in Phase 2/3 vascular trauma trial; BLA filing planned for Q4 2023
Humacyte, Inc.
- Enrollment completed in V005 trial; 68 patients received HAV, 51 in primary efficacy analysis for extremity trauma.
- Top-line results expected in Q3 2023; BLA submission to FDA planned for Q4 2023.
- RMAT designation from FDA received in May 2023 increases chance of priority review.
- Ukraine humanitarian program treated 19 trauma patients; data will be included in BLA.
- HAV has >1,000 patient-years of experience across multiple indications.