If approved, Filspari would be the first medication indicated for FSGS, a rare and serious kidney disorder driven by proteinuria, the company said.
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).
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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, a rare and serious kidney disorder driven by proteinuria that leads to progressive kidney function loss and kidney failure, the company said.
Shares of the company soared 16% in the pre-market session.
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