Humacyte plans supplemental BLA for atev dialysis access
Humacyte says it plans to file a supplemental BLA with the FDA for atev in dialysis access in November 2026, seeking a second approved indication backed by three phase 3 studies.
HUMA Humacyte confirms plans for atev supplemental BLA filing for dialysis access following FDA discussions Humacyte - to file supplemental BLA with FDA for atev in dialysis access in November 2026 - Seeks to add dialysis access as second approved indication for atev - Supplemental BLA to be supported by three phase 3 studies of atev