VIS-649

Otsuka has filed a Biologics License Application with the FDA for sibeprenlimab, a monoclonal antibody that selectively inhibits APRIL, a key cytokine in IgA nephropathy pathogenesis.

Outlook Therapeutics' ONS-5010 failed to meet the noninferiority endpoint in a Phase III wet AMD trial, impacting company shares but BLA resubmission is still planned for early 2025.

Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo.