Otsuka Holdings Co. Ltd., OTSKF, 4578.T, FDA Calendar, PDUFA Date

Company Name	Otsuka Holdings Co., Ltd. OTSKF, 4578.T
Drug Name	Sibeprenlimab (BLA)
Event Name	FDA decision on Sibeprenlimab in the treatment of Immunoglobulin A Nephropathy (IgAN) in adults
Event Date	11/28/2025
Outcome Date
Outcome	Pending
Drug Status	Priority review
Rival Drugs	Sibeprenlimab, if approved, will have to compete with Calliditas Therapeutics' TARPEYO, Novartis' FABHALTA, and VANRAFIA, Travere Therapeutics' FILSPARI
Market Potential
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