Roche's SatraGO-1 posts completed Phase III results; CellCept gets four-formulation label update

Roche closed out the week with topline results from a completed ophthalmology trial alongside a coordinated set of FDA approvals for CellCept.

• Roche's Phase III study of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease¹, known as "SatraGO-1," is now completed, with 131 participants enrolled¹ and results first posted July 31, 2026. The primary endpoint tracked the percentage of participants with active disease who achieved at least a 2 millimeter reduction in proptosis from baseline to Week 24 in the study eye, without a corresponding 2 mm or greater worsening in the fellow eye¹.
• FDA approved a REMS supplement and a labeling supplement for CellCept oral suspension (mycophenolate mofetil, 200mg/mL), with a submission status date of 2026-07-29^2,3,4,5.
• FDA approved matching REMS and labeling supplements for CellCept 500mg tablets, with a submission status date of 2026-07-29.
• FDA approved parallel REMS and labeling supplements for CellCept 250mg capsules, with a submission status date of 2026-07-29.
• FDA approved REMS and labeling supplements for CellCept injectable (mycophenolate mofetil hydrochloride, 500mg/vial), with a submission status date of 2026-07-29.