Shares of Travere Therapeutics (NASDAQ:TVTX) plunged around 33% on Tuesday after the company disclosed that U.S. regulators have asked for additional data related to its treatment for a rare kidney condition.
Travere said it has received information requests from the U.S. Food and Drug Administration aimed at better defining the clinical benefit of Filspari in patients with focal segmental glomerulosclerosis (FSGS). The company has already submitted responses addressing the FDA’s questions, which are now under review.
The timing has heightened uncertainty for investors, as the Prescription Drug User Fee Act (PDUFA) decision date for the supplemental new drug application falls on Tuesday. Market participants now see a range of potential outcomes, including a delayed ruling while the FDA evaluates the new information, issuance of a complete response letter requiring further studies, or no immediate regulatory action.
Evercore ISI analyst Gavin Clark-Gartner said that at roughly $22 per share, the stock had been reflecting approval odds of about 33%. He suggested that a requirement for additional efficacy trials could drive the share price down to around $12, while a positive approval outcome could lift it to approximately $43.
Stifel reiterated its Hold rating on Travere, flagging concerns over the approvability of Filspari for FSGS following a failed study. While acknowledging that regulatory delays have become more common and approval remains possible, the firm said a complete response letter “is not off the table” and could push the stock into the “low-teens.”
Outside the FSGS review, Travere reported continued momentum for Filspari in its approved IgAN indication, with fourth-quarter patient additions rising to 908 from 731 in the prior quarter.