By Colin Kellaher
Travere Therapeutics shares rose sharply in early trading Tuesday after the biopharmaceutical company said it plans to seek expanded Food and Drug Administration approval of its kidney-disease drug Filspari in focal segmental glomerulosclerosis, or FSGS, around the end of March.
Shares of the San Diego company were recently up 9.8% at $23.16 in premarket trading.
Travere said the filing will be based on existing data results from its Phase 3 and Phase 2 interventional studies of Filspari in the rare kidney disorder, which is a leading cause of kidney failure.
The company said there are currently no FDA-approved treatments for FSGS, a condition in which the kidney's filtering units become scarred or hardened, leading to proteinuria (protein in the urine), kidney failure and other complications.
Travere said the results of its studies are in alignment with the recent findings of a group of experts that lowering proteinuria levels could be a better gauge of how well treatments for FSGS are working.
Filspari is currently approved to slow kidney-function decline in adults with the chronic kidney disease primary immunoglobulin A nephropathy who are at risk for disease progression.
Travere reported Filspari net product sales of nearly $82.6 million for the first nine months of 2024.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 11, 2025 08:43 ET (13:43 GMT)
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