Item 8.01 Other Events.
OnMay 16, 2022 ,Travere Therapeutics, Inc. (the "Company") announced that theU.S. Food and Drug Administration ("FDA") has accepted and granted Priority Review of its New Drug Application ("NDA") under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy ("IgAN"). The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss the application and has assigned a Prescription Drug User Fee Act (PDUFA) target action date ofNovember 17, 2022 .
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 references relating to theFDA's potential approval of the Company's NDA for sparsentan for the treatment of IgAN by the target action date ofNovember 17, 2022 , or at all, and the expectation around any potential future request by the FDA to hold an advisory committee meeting related to the application. 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 Subpart H accelerated approval pathway. There is no guarantee that the FDA will grant accelerated approval 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 endedMarch 31, 2022 , as filed with theSEC onMay 5, 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:May 16, 2022 By:
/s/
Senior Vice President, General
Title: Counsel and Secretary
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