Travere Therapeutics Announces Confirmatory Data From The Phase 3 PROTECT Study Of FILSPARI Demonstrating Long-Term Kidney Function Preservation In IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint Versus Active Control, Irbesartan
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Travere Therapeutics has announced confirmatory data from the Phase 3 PROTECT study of FILSPARI, demonstrating long-term kidney function preservation in IgA Nephropathy. Although the drug narrowly missed the eGFR total slope endpoint versus active control, Irbesartan, it achieved a clinically meaningful difference. The company plans to meet with regulators and expects to submit a supplemental New Drug Application (sNDA) in 1H 2024 for full approval in the U.S.
September 21, 2023 | 11:34 am
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Travere Therapeutics' FILSPARI has shown promising results in the Phase 3 PROTECT study, which could potentially lead to a new revenue stream for the company if the drug gets full approval in the U.S.
The positive results from the Phase 3 PROTECT study of FILSPARI indicate that the drug has potential for long-term kidney function preservation in IgA Nephropathy. This could potentially lead to a new revenue stream for Travere Therapeutics if the drug gets full approval in the U.S. The company's stock price is likely to be positively impacted by this news in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100