Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions
Humacyte confirmed plans to file a supplemental BLA for its ATEV product in dialysis access by November 2026, following constructive discussions with the FDA. The filing will be backed by Phase 3 data from three studies, including V012 results showing women gained an average of three more months catheter-free compared to the standard of care.
Key figures
- Drug Name
- ATEV
- Phase Of Trial
- Phase 3
- Filing timeline
- November 2026
- Addressable population us
- 500000
- Months catheter free advantage
- 3
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