Travere Therapeutics Shares Fall After FDA Extends Filspari Review
By Katherine Hamilton
Travere Therapeutics shares slid after the company said the Food and Drug Administration extended the review timeline for its drug Filspari.
The stock dropped 33% to $22.71 on Tuesday. Shares are down about 8% over the past three months.
The San Diego biopharmaceutical company said it had submitted responses requested by the FDA to further characterize the clinical benefit of Filspari, which is designed to treat the rare kidney disorder focal segmental glomerulosclerosis.
The FDA decided the additional responses constituted a major amendment to the supplemental new drug application for Filspari and extended the action date accordingly, Travere said.
The new PDUFA, or prescription drug user fee act, target action date is April 13.
Filspari is already approved by the FDA and the European Medicines Agency to slow kidney function decline in adults with IgA nephropathy.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
January 13, 2026 14:05 ET (19:05 GMT)
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