PDUFA originally January 13, 2026. Extended to April 13, 2026 after FDA received a major amendment to the sNDA in January 2026. Filspari is already approved for IgAN; FSGS approval would make it the first drug specifically indicated for FSGS. DUPLEX Phase 3 showed significant proteinuria reduction (did not meet primary eGFR slope endpoint over 108 weeks). AdCom initially planned — FDA later determined no AdCom needed.
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
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