Travere Therapeutics (TVTX) stock jumped 44% on Tuesday after the FDA approved FILSPARI (sparsentan) to treat focal segmental glomerulosclerosis — a rare kidney disease with no previously approved therapy.
Travere Therapeutics, Inc., TVTX
The approval covers adults and children aged 8 and older with FSGS who do not have nephrotic syndrome. This makes FILSPARI the first and only FDA-approved drug for FSGS.
It also marks the second rare kidney disease indication for FILSPARI, which already holds approval for IgA nephropathy.
Travere estimates the addressable U.S. population at more than 30,000 FSGS patients who meet the criteria — those without the three concurrent markers of nephrotic syndrome.
The approval was backed by the Phase 3 DUPLEX Study, described as the largest interventional trial ever run in FSGS.
Patients on FILSPARI saw a 46% reduction in proteinuria from baseline to Week 108. Those on the comparator drug, maximum-dose irbesartan, saw a 30% reduction.
In the sub-group without nephrotic syndrome specifically, FILSPARI delivered a 48% proteinuria reduction versus 27% for irbesartan.
FILSPARI-treated patients in that group also showed a benefit in eGFR, with a treatment difference of 1.1 mL/min/1.73 m² at Week 108.
The drug showed a safety profile comparable to irbesartan across both adult and pediatric patients — a clean read that will matter for commercial uptake.
Guggenheim analyst Vamil Divan raised his price target on TVTX to $54 from $49 and kept a Buy rating following the news.
Divan said the final label came in better than expected, noting the approved population was broader than the Street had assumed.
Specifically, the label covers both primary and secondary FSGS — not just the primary and genetic cases that analysts and management had been modeling as the base case.
That wider coverage opens a larger commercial opportunity than many had priced in.
TipRanks lists a separate analyst Buy rating with a $47 price target on the stock, and rates the technical sentiment signal as a Buy.
TVTX’s current market cap sits at approximately $2.67 billion following Tuesday’s move.
The FDA approval was announced April 13, 2026, with the stock reaction coming during Tuesday’s trading session.
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