FDA FULLY APPROVED April 13, 2026 — on PDUFA target date. FIRST AND ONLY FDA-APPROVED MEDICINE FOR FSGS. Approved to reduce proteinuria in adults and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. DUPLEX Phase 3 (n=371): 46% proteinuria reduction with sparsentan vs 30% with irbesartan at week 108 (non-nephrotic subgroup: 48% vs 27%). Total addressable population >30,000 FSGS patients + >100,000 combined with existing IgAN indication. Citi reiterated Buy/$48 target; JPMorgan Overweight/$41. TVTX +34% on approval day. Ligand (LGND) entitled to 9% royalty on worldwide net sales. Previously: PDUFA extended from Jan 13 to Apr 13, 2026 after FDA major amendment in January 2026.
⚠️ 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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