Travere fails to beat off-label blood pressure drug in phase 3 but plans talks with FDA anyway

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1. Travere Therapeutics' phase 3 trial of sparsentan for kidney disease missed its primary endpoint.

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2. The trial compared sparsentan to irbesartan, a drug used to treat focal segmental glomerulosclerosis (FSGS).

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3. After 108 weeks, the difference in estimated glomerular filtration rate (eGFR) total fell short of statistical significance.

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4. Failure on the primary endpoints led to a 24% drop in Travere's shares.

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5. Despite the setback, Travere plans to discuss potential paths to market with the FDA.

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6. The company cites positive trends in eGFR slope and proteinuria reduction as reasons to explore a possible registration path.

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7. Travere CEO Eric Dube believes the well-tolerated safety profile also supports this exploration.

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8. The company plans to conduct subgroup analyses before meeting with the FDA in the summer.

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9. William Rote, SVP of R&D at Travere, notes that the FDA has previously acknowledged the difficulty of studying FSGS.

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10. Rote also emphasizes the high unmet medical need for treating this rare disease.

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