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SAN DIEGO - Travere Therapeutics, Inc. (NASDAQ:TVTX) announced Wednesday that the U.S. Food and Drug Administration has determined an advisory committee is no longer needed for the review of FILSPARI (sparsentan) for focal segmental glomerulosclerosis (FSGS). The news contributed to the company’s strong recent performance, with shares gaining over 10% in the past week, according to InvestingPro data.
The supplemental New Drug Application (sNDA) remains under review with a target action date of January 13, 2026. If approved, FILSPARI would become the first FDA-approved medication specifically indicated for FSGS, a rare kidney disorder that can lead to kidney failure. The potential approval could further boost Travere’s impressive revenue growth, which InvestingPro data shows reached nearly 88% in the last twelve months.
"We are pleased with the progress of the sNDA to date and look forward to further supporting the FDA’s review of our application for FILSPARI in FSGS," said Eric Dube, president and chief executive officer of Travere Therapeutics, according to the company’s press release.
The application is supported by data from two clinical trials in FSGS patients - the Phase 3 DUPLEX Study and the Phase 2 DUET Study. These studies demonstrated that FILSPARI provided greater reductions in proteinuria compared to irbesartan, the active control. Results published in the New England Journal of Medicine showed statistically significant proteinuria remission at 36 weeks that was maintained through two years.
FILSPARI is currently approved by both the FDA and European Medicines Agency to slow kidney function decline in adults with IgA nephropathy, another rare kidney disease.
FSGS affects an estimated 40,000 patients in the U.S., with similar prevalence in Europe. The condition is characterized by protein leakage into the urine due to kidney filtration damage, which can lead to progressive scarring of the kidney and eventual kidney failure.
Travere stated it is continuing preparations for a potential commercial launch in January, pending FDA approval.
In other recent news, Travere Therapeutics reported second-quarter 2025 earnings that exceeded revenue forecasts, with the company generating $114.4 million compared to the anticipated $99.25 million. This represents a 15.26% revenue surprise, while the earnings per share loss of $0.14 was better than the expected loss of $0.30. Additionally, the U.S. Food and Drug Administration approved updated monitoring requirements for Travere’s kidney disease treatment, FILSPARI. The FDA’s decision reduced the frequency of liver function monitoring from monthly to every three months and removed the embryo-fetal toxicity monitoring requirement. Meanwhile, H.C. Wainwright raised its price target for Travere Therapeutics to $47.00 from $30.00, maintaining a Buy rating, following the FDA’s approval for FILSPARI. In contrast, Stifel lowered its price target to $20.00 from $23.00, citing uncertainty surrounding the approval timeline for Filspari in focal segmental glomerulosclerosis (FSGS). Furthermore, Travere Therapeutics presented positive long-term data from its Phase 1/2 COMPOSE study, showing significant reductions in total homocysteine and methionine levels in patients treated with pegtibatinase.
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