Travere Therapeutics Stock Soars Pre-market After FDA Waives Need For An Advisory Committee Meeting On Its Kidney Disorder Drug Application

Travere Therapeutics (TVTX) on Wednesday said that the U.S. Food and Drug Administration informed the company that it has waived the need for an advisory committee meeting regarding its application for Filspari in treating focal segmental glomerulosclerosis (FSGS).

The FDA is expected to decide on the company’s application by January 13, 2026. If approved, Filspari would be the first medication indicated for FSGS, the company said. FSGS is a rare and serious kidney disorder driven by proteinuria or protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. The disease leads to progressive kidney function loss and kidney failure and is estimated to affect more than 40,000 patients in the U.S., according to Travere.  

Shares of the company soared 16% in the pre-market session. On Stocktwits, retail sentiment around TVTX stock stayed within ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

CEO Eric Dube said that the company is pleased with the progress of its new application for Filspari to date and is continuing preparation for a successful commercial launch in January, if approved.

The company’s application is supported by data from mid-stage and late-stage studies where Filspari demonstrated rapid, superior, and sustained reductions in proteinuria when compared with the maximum labeled dose of the approved drug Irbesartan across adult and pediatric patients. The drug was also well-tolerated in the studies with a safety profile comparable to Irbesartan.

Filspari is already approved by the FDA to slow kidney function decline in adults with IgA nephropathy, a chronic autoimmune kidney disease characterized by the abnormal accumulation of immunoglobulin A (IgA) antibodies in the kidneys' filtering units. The new application by the company seeks to expand its use to the treatment of FSGS as well.

TVTX stock is up by 24% this year and by about 69% over the past 12 months. 

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