Travere climbs after FDA eases monitoring rules for kidney drug

Travere Therapeutics

28/08/2025 14:20

** Shares of drug developer Travere Therapeutics TVTX.O rise 8.7% to $18.96 premarket

** Co says the U.S. FDA approved a REMS update for its kidney disease drug, Filspari

** The update reduces liver monitoring from monthly to every three months

** The FDA also removed embryo-fetal toxicity monitoring requirements

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

** REMS, Risk Evaluation and Mitigation Strategy, is a safety program required by the FDA to ensure a drug's benefits outweigh its risks by managing serious safety concerns

** "We are encouraged by the loosening of the REMS, which we think could incrementally open up the addressable patient population and provide a nice tailwind to the ongoing launch in IgAN" - Leerink Partners analyst Joseph Schwartz

** As of last close, stock up 0.1% YTD

 (Reporting by Kamal Choudhury in Bengaluru)

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