secwatch.observer — SEC 8-K summary
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Issuer:     Travere Therapeutics, Inc. (TVTX)
CIK:        0001438533
Form:       8-K
Filed at:   2023-05-31T23:59:59+00:00
Accession:  0001438533-23-000030
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Travere reports positive Phase 1/2 COMPOSE Cohort 6 data for pegtibatinase in HCU
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- Pegtibatinase 2.5 mg/kg twice weekly reduced total homocysteine (tHcy) by mean 67.1% vs placebo increase of 0.6%.
- All 4 treated patients achieved mean tHcy below 100 µM threshold; one patient with low baseline achieved normalization.
- No treatment-related serious adverse events, anaphylaxis, or discontinuations in cohort 6.
- Methionine reduced and cystathionine elevated, consistent with desired CBS enzyme activity.
- Company plans to initiate Phase 3 program by end of 2023 after regulatory engagement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1438533/000143853323000030/0001438533-23-000030-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1438533/000143853323000030/tvtx-20230531.htm
  HTML page:      https://secwatch.observer/filing/0001438533-23-000030

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