secwatch.observer — SEC 8-K summary
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Issuer:     Travere Therapeutics, Inc. (TVTX)
CIK:        0001438533
Form:       8-K
Filed at:   2023-09-21T23:59:59+00:00
Accession:  0001193125-23-239098
Event type: other_material
Sentiment:  neutral
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Travere's FILSPARI misses eGFR total slope endpoint but achieves chronic slope significance in IgAN
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- eGFR total slope difference vs irbesartan 1.0 mL/min/1.73m2 per year, p=0.058 (missed statistical significance).
- eGFR chronic slope difference 1.1 mL/min/1.73m2 per year, p=0.037 (statistically significant).
- Company to submit sNDA for full FDA approval of FILSPARI in IgAN in first half of 2024.
- EU CMA decision for sparsentan in IgAN expected from CHMP around end of 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1438533/000119312523239098/0001193125-23-239098-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1438533/000119312523239098/d530177d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-239098

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