Travere Therapeutics Files 8-K

TL;DR

Travere Therapeutics filed an 8-K on Feb 11, 2025. No major news yet.

AI Summary

On February 11, 2025, Travere Therapeutics, Inc. filed an 8-K report. The filing indicates that the company is providing information under "Other Events." No specific material events or transactions are detailed in the provided excerpt, suggesting it may be a routine filing or related to ongoing business operations.

Why It Matters

This filing indicates Travere Therapeutics is submitting a current report to the SEC, which could contain updates on material events affecting the company.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without specific disclosures of negative events, indicating a low immediate risk.

Key Players & Entities

• Travere Therapeutics, Inc. (company) — Registrant
• February 11, 2025 (date) — Date of earliest event reported
• 001-36257 (other) — Commission File Number
• 27-4842691 (other) — I.R.S. Employer Identification No.
• 3611 Valley Centre Drive, Suite 300 (location) — Principal Executive Offices Address
• San Diego, CA 92130 (location) — Principal Executive Offices City, State, Zip
• 888-969-7879 (phone) — Registrant's Telephone Number

FAQ

Key Financial Figures

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

Filing Documents

• tvtx-20250211.htm (8-K) — 35KB
• 0001438533-25-000004.txt ( ) — 161KB
• tvtx-20250211.xsd (EX-101.SCH) — 2KB
• tvtx-20250211_lab.xml (EX-101.LAB) — 22KB
• tvtx-20250211_pre.xml (EX-101.PRE) — 13KB
• tvtx-20250211_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On February 11, 2025, Travere Therapeutics, Inc. (the "Company") announced that it has completed its Type C meeting with the U.S. Food and Drug Administration ("FDA") and plans to submit a supplemental New Drug Application ("sNDA") seeking traditional approval of FILSPARI for focal segmental glomerulosclerosis ("FSGS"). The sNDA will be based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI and is expected to be submitted around the end of the first quarter of 2025. The Type C Meeting follows the recent public workshop led by the PARASOL (Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis [FSGS]) workgroup. The principal finding from PARASOL was that in FSGS, reduction in proteinuria over 24 months is strongly associated with a reduction in the risk of kidney failure, and responder definitions based on thresholds of proteinuria are both biologically plausible and strongly supported by epidemiological data. If approved, FILSPARI could be the first and only approved medicine indicated for FSGS, a rare kidney disorder and leading cause of kidney failure.

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: plans and expectations regarding the submission of an sNDA for FILSPARI in FSGS, and expectations regarding the timing and outcome thereof; statements regarding the potential for FILSPARI to be the first and only approved medicine indicated for FSGS; and expectations regarding the potential impact that the PARASOL group's findings could have on the review of the sNDA. 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 related to the Company's planned submission of an sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will accept the sNDA for filing, will grant priority review of the sNDA or grant approval of FILSPARI for FSGS. The Company also faces risks related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and u

View Full Filing

View this 8-K filing on SEC EDGAR