Vertex manufactured insulin-producing cells that freed ten of twelve patients from injections. The product is not a drug. It is a replacement organ grown from stem cells and shipped in a vial. Ten of twelve patients in Vertex's FORWARD-101 trial stopped injecting insulin. The cells that replaced their pancreatic function were not harvested from a donor. They were manufactured from stem cells in a cleanroom, shipped in a vial, and infused through a standard procedure. Vertex calls it a cell therapy. The FDA is evaluating it as a biologic. What it actually is, is a replacement organ produced at industrial scale. Zimislecel received Regenerative Medicine Advanced Therapy designation from the FDA and PRIME designation from the EMA. The Phase 3 pivotal trial is actively dosing roughly fifty patients. The company originally guided a 2030 regulatory submission; it now says 2026, with updated timelines expected in coming months. Two patients in the trial died.…