The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.

A disrupted balance between T-effector and T-regulatory cells, together with the activation of autoreactive or alloreactive B cells that generate pathogenic antibodies, is a defining feature of autoimmune diseases and transplant rejection and contributes to their often poor outcomes.

Mabloc LLC has established a strategic partnership with Instituto Butantan to co-develop and manufacture MBL-YFV-01, a monoclonal antibody therapy for yellow fever virus (YFV) infection, including emergency post-exposure use.

Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.

Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.

A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.

Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.

Researchers at Calluna Pharma AS, Agiana Pharmaceuticals AS and Roskilde University have developed the first humanized IgG4 antibody that inhibits S100A4, which is a calcium-binding protein that helps drive fibrotic inflammatory diseases.

The overexpression of fibroblast growth factor receptor 2b (FGFR2b) is tied to tumor progression in several malignancies, such as cholangiocarcinoma, HER2-negative gastric cancer and breast cancer. Lunan Pharmaceutical Group Corp. has developed a novel IgG1 monoclonal antibody against FGFR2b, LNF-2102, for the potential treatment of cancer.