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Aug 08, 2026
The FDA approved Tregzi (Orca-T), a first-of-its-kind regulatory T cell-based immunotherapy, for adults with blood cancers undergoing matched donor stem cell transplants. Approval was based on the PRECISION-T trial, in which 78% of treated patients achieved chronic GVHD-free survival at one year versus 38.4% with standard transplant.
Jul 16, 2026
Phase 3 MAJESTY trial results show obinutuzumab led to 37% complete remission at 2 years vs 6% with tacrolimus in primary membranous nephropathy, with comparable safety. Genentech announced the positive data in February 2026, positioning obinutuzumab as a potential first approved therapy for PMN.
Jun 22, 2026
Eledon Pharmaceuticals reported positive long-term Phase 2 BESTOW trial results for tegoprubart in kidney transplant, showing sustained kidney function benefits and improved patient outcomes versus tacrolimus. The company outlined plans for a Phase 3 registrational trial and seeks an FDA meeting in early 2027. Safety data indicated lower adverse event rates with tegoprubart.
May 26, 2026
The global CNS biomarkers market is projected to reach USD 26.13 billion by 2035, amyloid beta therapeutics USD 26.50 billion, and calcineurin inhibitors USD 20.88 billion. AI integration is driving innovation across all three markets.
Mar 25, 2026
Interim results from the ABC phase 1/2b trial show a calcineurin inhibitor-free GVHD prevention regimen combining posttransplant cyclophosphamide, bortezomib, and abatacept achieved low GVHD rates and favorable survival outcomes. The approach enables earlier introduction of posttransplant maintenance therapies while reducing toxicity associated with conventional immunosuppressants.
Mar 06, 2026
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
Feb 25, 2026
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
Feb 16, 2026
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
Feb 16, 2026
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Feb 16, 2026
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Feb 16, 2026
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
