Travere Therapeutics Files 8-K with Exhibits

TL;DR

Travere Therapeutics filed a routine 8-K with SEC, mostly exhibits. No major news.

AI Summary

On April 24, 2024, Travere Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, indicating a routine update rather than a major event. No specific financial figures or significant business developments were detailed in the provided excerpt.

Why It Matters

This 8-K filing serves as a standard disclosure for Travere Therapeutics, Inc., providing updates on financial statements and exhibits to the SEC.

Risk Assessment

Risk Level: low — The filing appears to be a standard procedural disclosure with no immediate indication of significant financial or operational changes.

Key Players & Entities

• Travere Therapeutics, Inc. (company) — Registrant
• Retrophin, Inc. (company) — Former Company Name
• Desert Gateway, Inc. (company) — Former Company Name
• 20240424 (date) — Report Date

FAQ

Key Financial Figures

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

Filing Documents

• tvtx-20240424.htm (8-K) — 38KB
• 0001438533-24-000016.txt ( ) — 164KB
• tvtx-20240424.xsd (EX-101.SCH) — 2KB
• tvtx-20240424_lab.xml (EX-101.LAB) — 22KB
• tvtx-20240424_pre.xml (EX-101.PRE) — 13KB
• tvtx-20240424_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On April 24, 2024, Travere Therapeutics, Inc. (the "Company") and CSL Vifor announced that the European Commission has granted conditional marketing authorization ("CMA") for FILSPARI (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 CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. The European Commission's decision follows the positive opinion from the Committee for Medicinal Products for Human Use ("CHMP") in February 2024, based on results from the pivotal Phase 3 PROTECT Study of FILSPARI in IgAN. 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 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand. CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.

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 approval process and expectations for the launch of FILSPARI in European markets and the anticipated timing thereof. 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 the planned launch of FILSPARI in certain European markets and the anticipated timing thereof, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, as well as risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI. The risks and uncertainties the Company faces with respect to its preclinical and clinical stage pipeline include risk tha

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: April 24, 2024 By: /s/ Eric Dube Name: Eric Dube Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR