Shares of Travere Therapeutics were halted from trading after falling more than 30% in intraday trading on January 13, 2026, after the U.S. Food and Drug Administration extended the review timeline for the supplemental New Drug Application for FILSPARI in focal segmental glomerulosclerosis, setting a new PDUFA target action date of April 13, 2026. The FDA stated that additional responses submitted by the company constituted a major amendment and requested further data to characterize clinical benefit. Block & Leviton is investigating whether Travere Therapeutics adequately disclosed the risk of a review extension and whether prior communications regarding the regulatory timeline were misleading.
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