Humacyte, Inc.
ATEV
dialysis access
Countdown
177days
FDA decision · ~ Dec 31, 2026 estimated
What's at stake
The FDA's approval decision on ATEV for dialysis access is due ~ Dec 31, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“Humacyte plans to file a supplemental Biologic License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026.”