Travere Therapeutics Files 8-K for Financials

TL;DR

Travere Therapeutics filed an 8-K for financial statements and exhibits. No major news.

AI Summary

On September 5, 2024, Travere Therapeutics, Inc. filed an 8-K report. The filing primarily concerns the company's financial statements and exhibits, with no specific material events or other significant business updates detailed in the provided text.

Why It Matters

This filing indicates that Travere Therapeutics is providing updated financial information and exhibits to the SEC, which is standard procedure for public companies.

Risk Assessment

Risk Level: low — The filing is a routine submission of financial statements and exhibits, not indicating any new risks or significant events.

Key Numbers

• 001-36257 — SEC File Number (Identifies the company's filing with the SEC.)
• 27-4842691 — I.R.S. Employer Identification No. (Company's tax identification number.)

Key Players & Entities

• Travere Therapeutics, Inc. (company) — Registrant
• Retrophin, Inc. (company) — Former company name
• Desert Gateway, Inc. (company) — Former company name
• San Diego, CA (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-20240905.htm (8-K) — 44KB
• 0001438533-24-000035.txt ( ) — 172KB
• tvtx-20240905.xsd (EX-101.SCH) — 2KB
• tvtx-20240905_lab.xml (EX-101.LAB) — 22KB
• tvtx-20240905_pre.xml (EX-101.PRE) — 13KB
• tvtx-20240905_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On September 5, 2024, Travere Therapeutics, Inc. (the "Company") announced that the U.S. Food and Drug Administration (FDA) has granted full approval to FILSPARI (sparsentan) to slow kidney function decline in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. FILSPARI was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. FILSPARI is the only oral, once-daily, non-immunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II). The two-year efficacy data contained in the FDA-approved label is a modified intention to treat (ITT) analysis, and as preferred by the FDA, evaluates data from all patients regardless of treatment discontinuation. In the final analysis of the 404 randomized patients, FILSPARI significantly reduced the rate of decline in kidney function from baseline to Week 110 compared to irbesartan. In the ITT analysis included in the label, the mean eGFR slope from baseline to Week 110 was -3.0 mL/min/1.73 m 2 /year for FILSPARI and -4.2 mL/min/1.73 m 2 /year for irbesartan, corresponding to a statistically significant treatment effect of 1.2 mL/ min/1.73 m 2 /year (p=0.0168). The positive treatment effects on proteinuria compared to the active control irbesartan that were observed at Week 36 were durable out to the two-year measurement period. Additional results from the PROTECT Study demonstrated the benefit of FILSPARI on absolute eGFR accrued over time and by Week 110 resulted in a 3.8 mL/min/1.73 m 2 difference in the mean change from baseline between FILSPARI and irbesartan. Results from the PROTECT Study showed that FILSPA

Forward-Looking Statements

Forward-Looking Statements This report 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 "on-track," "positioned," "look forward to," "will," "would," "may," "might," "believes," "anticipates," "plans," "expects," "intends," "potential," 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 planned engagement with the FDA and plans to submit an sNDA for a potential modification to the liver-monitoring REMS. 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 its preclinical and clinical stage pipeline. Specifically, the Company faces risks associated with the ongoing commercial launch of FILSPARI, 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 that the Company's cl

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: September 5, 2024 By: /s/ Eric Dube Name: Eric Dube Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR