secwatch.observer — SEC 8-K summary
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Issuer:     Travere Therapeutics, Inc. (TVTX)
CIK:        0001438533
Form:       8-K
Filed at:   2023-05-01T23:59:59+00:00
Accession:  0001438533-23-000018
Event type: other_material
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Travere's sparsentan misses primary eGFR endpoint in Phase 3 FSGS study; proteinuria trends favorable
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- eGFR total slope difference 0.3 mL/min/1.73m2/yr favoring sparsentan (p=0.7491), not statistically significant.
- eGFR chronic slope difference 0.9 mL/min/1.73m2/yr (p=0.4203), also not significant.
- Proteinuria reduced 50% with sparsentan vs 32% with irbesartan at week 108; FPRE 38% vs 23%.
- Company plans to engage FDA and EMA to explore potential path for regulatory submission.
- Sparsentan well-tolerated with safety profile comparable to irbesartan through 108 weeks.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1438533/000143853323000018/0001438533-23-000018-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1438533/000143853323000018/tvtx-20230501.htm
  HTML page:      https://secwatch.observer/filing/0001438533-23-000018

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