Travere Therapeutics, Inc. (NASDAQ: TVTX) saw its stock plummet by 5.43% during the intraday session on Wednesday, as investors reacted to the U.S. Food and Drug Administration (FDA) extending the review timeline for its supplemental New Drug Application (sNDA) for Filspari, a treatment for focal segmental glomerulosclerosis (FSGS).

The FDA's delay, which pushes the target action date to April 13, has raised concerns among investors about the drug's approval timeline. Filspari is a critical product for Travere, as it would be the first medication indicated for FSGS, a rare and serious kidney disorder. The company recently submitted responses to the FDA's requests for additional information to characterize the clinical benefit of Filspari, but no further details on safety or manufacturing were required.