Item 8.01 Other Events.
OnAugust 22, 2022 ,Travere Therapeutics, Inc. (the "Company") and CSL Vifor (formerly known asVifor (International) ) announced that theEuropean Medicines Agency ("EMA") has accepted for review the conditional marketing authorization application of sparsentan for the treatment of IgA nephropathy ("IgAN"). A review decision is expected in the second half of 2023.
Forward-Looking Statements
This Current Report on Form 8-K contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include the timing of the EMA's review decision and the outcome of that decision. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the conditional marketing authorization approval pathway. There is no guarantee that the EMA will provide a review decision on the timeline expected or that it will grant conditional marketing authorization of sparsentan for IgAN or that sparsentan will be approved at all. In addition, such risks and uncertainties may include those described in the Company's filings with theSecurities and Exchange Commission , including under the "Risk Factors" heading of the Company's quarterly report on Form 10-Q for the quarter endedJune 30, 2022 , as filed with theSEC onAugust 4, 2022 . You are cautioned not to place undue reliance on any forward-looking statements as there are important factors that could cause actual results to differ materially from those in any forward-looking statements, many of which are beyond our control. Except to the extent required by law, the Company undertakes no obligation to publicly update any forward-looking statement.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
TRAVERE THERAPEUTICS, INC. Dated:August 22, 2022 By:
/s/
Senior Vice President, General
Title: Counsel and Secretary
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