Item 8.01 Other Events.
OnMarch 21, 2022 ,Travere Therapeutics, Inc. (the "Company") announced that it has submitted a New Drug Application ("NDA") to theU.S. Food and Drug Administration ("FDA") under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy ("IgAN"). The Company expects to receive notice regarding the acceptance of the NDA, as well as the timeline for NDA review, from the FDA inMay 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 to the Company's current expectations around the timeline for receiving notice regarding the acceptance of the NDA and the timeline for NDA review. 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 accept for filing the Company's NDA for sparsentan for IgAN under the Subpart H approval pathway, 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 annual report on Form 10-K for the year endedDecember 31, 2021 , as filed with theSEC onFebruary 24, 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:March 21, 2022 By:
/s/
Senior Vice President, General
Title: Counsel and Secretary
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