Business Wire

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a pre-specified interim ...
Business Wire

Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

The FDA target action date (PDUFA date) is set for November 28, 2025 If approved, sibeprenlimab would offer patients a convenient single-dose prefilled syringe for subcutaneous injection every four ...
Medscape

KDIGO Issues New Guideline for Managing IgAN and IgAV

Kidney Disease: Improving Global Outcomes (KDIGO) has issued comprehensive, evidence-based recommendations for clinicians managing immunoglobulin A nephropathy (IgAN) and immunoglobulin A vasculitis ...
Seeking Alpha

Vera Therapeutics Atacicept: Promising Step In IgAN, But Crowded Road Ahead (Rating Downgrade)

Atacicept met its Phase 3 proteinuria reduction endpoint, supporting optimism for Vera's accelerated FDA approval filing later this year. Despite positive interim data, full kidney function (eGFR) ...