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TVTX — Travere Therapeutics News Story

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Travere jumps on US FDA's nod to skip advisory panel for kidney disease drug

Updates

** Shares of drug developer Travere Therapeutics TVTX.O rise 30% to more than three-year high of $28.07

** Stock set for its biggest one-day pct. gain in over 10 years, if gains hold

** Co says U.S. FDA no longer needs advisory committee meeting for supplemental application of its kidney disease drug, Filspari, for treatment of focal segmental glomerulosclerosis, a rare kidney disease

** Co is seeking expanded approval for Filspari, with target decision date of January 13

** "Removal of this step further reduces uncertainty and reinforces our confidence in what we continue to view as a >$2Bn US commercial opportunity in FSGS, where Filspari would be the first FDA-approved therapy for this rare kidney disorder," Guggenheim analyst Vamil Divan says

** Filspari, approved in 2023 for IgA nephropathy, carries boxed warnings for liver damage and birth defects

** Including session's moves, stock up 58% YTD

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))

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