Travere Therapeutics, Inc. (NASDAQ:TVTX) stock fell Tuesday as the company faces significant selling pressure following a corporate update that raised concerns among investors.
The stock’s decline comes as the broader market is experiencing mixed performance, with the S&P 500 down 0.16% and the Nasdaq slightly up by 0.02%.
FDA Review Update
On Tuesday, the U.S. Food and Drug Administration (FDA) extended the review timeline of Travere Therapeutics’ supplemental New Drug Application (sNDA) for Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS).
The new Prescription Drug User Fee Act (PDUFA) target action date is April 13.
The extension follows the recent submission of responses requested by the FDA to further characterize the clinical benefit of Filspari.
No additional information relating to the safety or manufacturing of Filspari has been requested.
In its preliminary financial results on Tuesday, the company said it received additional information requests from the FDA to further characterize the clinical benefit of Filspari and recently submitted responses.
If …