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Investing.com -- Shares of Travere Therapeutics, Inc. (NASDAQ: TVTX ) rose 7% following the company's announcement of its intent to submit a supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disorder.

The San Diego-based biopharmaceutical company reported on February 11, 2025, that it had completed a Type C meeting with the U.S. Food and Drug Administration (FDA), aligning on its plan to submit the sNDA by the end of the first quarter of 2025. If approved, FILSPARI could become the first and only medicine indicated for FSGS, a condition that is a leading cause of kidney failure and affects over 40,000 individuals in the U.S.

The upcoming sNDA submission will be based on data from the Phase 3 DUPLEX and Phase 2 DUET studies, which are among the largest interventional studies conducted for FSGS to date. The company's CEO, Eric Dube, Ph.D., expressed satisfaction with the progress and emphasized the urgent need for treatment options for this serious condition. The results from the studies are expected to align with recent findings by the PARASOL workgroup, which indicated the significance of proteinuria reduction in FSGS patients.

The PARASOL workgroup's principal finding was that a reduction in proteinuria over 24 months is strongly associated with a decreased risk of kidney failure. Definitions of responders based on thresholds of proteinuria were deemed biologically plausible and supported by epidemiological data.

Investors are showing optimism as the stock moves upward, reflecting confidence in the potential market opportunity for FILSPARI and the company's advancement towards regulatory approval.

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