secwatch.observer — SEC 8-K summary
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Issuer:     Travere Therapeutics, Inc. (TVTX)
CIK:        0001438533
Form:       8-K
Filed at:   2024-10-31T23:59:59+00:00
Accession:  0001438533-24-000046
Event type: earnings
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Travere reports Q3 net loss $54.8M; FILSPARI sales $35.6M, full FDA approval in IgAN
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- Net product sales $61.0M (FILSPARI $35.6M); 505 new PSFs in Q3; 2,989 total since launch.
- Full FDA approval for FILSPARI in IgAN on Sept 5, 2024; broader label and orphan exclusivity to 2031.
- R&D $51.7M, SG&A $65.6M; net loss $54.8M ($0.70/share); cash $277.4M.
- sNDA submitted to modify liver monitoring; Type C meeting with FDA scheduled for FSGS path.
- Voluntary halt of enrollment in Phase 3 HARMONY (pegtibatinase) due to manufacturing scale-up; restart expected 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1438533/000143853324000046/0001438533-24-000046-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1438533/000143853324000046/tvtx-20241031.htm
  HTML page:      https://secwatch.observer/filing/0001438533-24-000046

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer