Travere Therapeutics Files 8-K on Feb 23 for 'Other Events'

TL;DR

**Travere Therapeutics just dropped an 8-K on Feb 23, signaling an 'Other Event' that could be important.**

AI Summary

Travere Therapeutics, Inc. filed an 8-K on February 23, 2024, reporting an "Other Event" and "Financial Statements and Exhibits." The filing indicates a current report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, with the earliest event reported also on February 23, 2024. The company, incorporated in Delaware with IRS Employer Identification No. 27-4842691, is headquartered at 3611 Valley Centre Drive, Suite 300, San Diego, CA 92130.

Why It Matters

This filing signals that Travere Therapeutics has an event or information deemed significant enough to warrant immediate disclosure to investors, potentially impacting future company operations or financial outlook.

Risk Assessment

Risk Level: low — The 8-K filing itself is a routine disclosure and does not inherently indicate a high risk without further details on the 'Other Event'.

Key Players & Entities

• Travere Therapeutics, Inc. (company) — Registrant
• February 23, 2024 (date) — Date of earliest event reported and filing date
• Delaware (location) — State of incorporation
• 27-4842691 (other) — IRS Employer Identification No.
• 3611 Valley Centre Drive, Suite 300, San Diego, CA 92130 (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share TVTX The Nasdaq Global Marke

Filing Documents

• tvtx-20240223.htm (8-K) — 38KB
• 0001438533-24-000007.txt ( ) — 166KB
• tvtx-20240223.xsd (EX-101.SCH) — 2KB
• tvtx-20240223_lab.xml (EX-101.LAB) — 25KB
• tvtx-20240223_pre.xml (EX-101.PRE) — 13KB
• tvtx-20240223_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On February 23, 2024, Travere Therapeutics, Inc. (the "Company") and CSL Vifor announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the conditional marketing authorization (CMA) application for sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio 0.75 g/g). The positive CHMP opinion is based on results from the Company's pivotal Phase 3 PROTECT Study of sparsentan in IgAN. The CHMP opinion provides the basis for the European Commission's final decision regarding the potential CMA for sparsentan. If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. Sparsentan is currently marketed in the U.S. under accelerated approval granted by the U.S. Food and Drug Administration under the brand name FILSPARI to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio 1.5 g/g. In August 2022, Travere Therapeutics and CSL Vifor announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA. The European Commission previously granted Orphan Medicinal Product Designation to sparsentan for the treatment of IgAN. In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.

Forward-Looking Statements

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. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements regarding the potential conditional marketing authorization of sparsentan for the treatment of IgAN in the European Union, Iceland, Liechtenstein and Norway and the anticipated timing thereof, including the potential timing and outcome of the European Commission's decision; and the potential for sparsentan to be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN in the EU. 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, as well as risks and uncertainties associated with the Company's business and finances in general, the success of its commercial products and risks and uncertainties associated with the Company's preclinical and clinical stage pipeline. Specifically, the Company faces risks associated with market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, as well as risks associated with the

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). 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: February 23, 2024 By: /s/ Eric Dube Name: Eric Dube Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR