# FDA Wants Orca Bio's Cancer Therapy. Fix the Factory. - Date: 2026-04-02 - Category: Biotech & Life Sciences The FDA hit Orca Bio with a 3-month manufacturing delay — not a safety problem. The Phase 3 data remains striking: 78% of transplant patients alive without severe chronic GVHD at one year, versus 38.4% on the standard regimen. ---