Travere Therapeutics Stock Slumps After FDA Extends Drug Review Timeline To April
Synopsis
According to Travere, Filspari would be the first medication indicated for focal segmental glomerulosclerosis if approved.
Shares of Travere Therapeutics, Inc., (TVTX) traded 33% lower on Tuesday after the company announced that U.S. Food and Drug Administration (FDA) has extended the review timeline for its application seeking approval of Filspari in focal segmental glomerulosclerosis.
The agency is now expected to decide on the application by April 13, 2026. The agency was initially expected to rule on the application by Jan. 13.
The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. The company submitted responses and the agency determined that the responses constitute a major amendment to the application, and extended the review timeline, the company said.
According to Travere, Filspari would be the first medication indicated for focal segmental glomerulosclerosis if approved.
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