secwatch.observer — SEC 8-K summary
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Issuer:     Travere Therapeutics, Inc. (TVTX)
CIK:        0001438533
Form:       8-K
Filed at:   2024-09-06T23:59:59+00:00
Accession:  0001438533-24-000035
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA grants full approval to Travere's FILSPARI for IgA nephropathy based on PROTECT study
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- FDA full approval for FILSPARI (sparsentan) to slow kidney function decline in adults with primary IgAN at risk of disease progression.
- PROTECT Study: FILSPARI showed mean eGFR slope -3.0 vs -4.2 mL/min/1.73 m2/year for irbesartan (p=0.0168), a 1.2 mL/min/year treatment effect.
- FILSPARI reduced proteinuria by 49.8% vs 15.1% at Week 36 (p<0.0001); effect durable to two years.
- Company plans to submit sNDA for potential modification to liver-monitoring REMS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1438533/000143853324000035/0001438533-24-000035-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1438533/000143853324000035/tvtx-20240905.htm
  HTML page:      https://secwatch.observer/filing/0001438533-24-000035

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