The U.S. Food and Drug Administration has approved the expanded use of ​Travere Therapeutics' drug to treat a rare kidney disorder, the company ‌said on Monday.

How a rare disease drugmaker won FDA approval after a clinical trial disappointed.

The U.S. Food and Drug Administration has extended its review for the expanded use of Travere Therapeutics’ drug to treat a type of rare kidney disorder, the drugmaker said on Tuesday.

The FDA expanded the label for Filspari on Monday to add another kidney condition. The drug is now the first therapy approved in the US for focal segmental glomerulosclerosis (FSGS).

Dimerix reports observational study data may support accelerated US approval for DMX-200 in FSGS kidney disease; Amicus holds US rights; Travere's Filspari awaits FDA decision.

How a rare disease drugmaker won FDA approval after a clinical trial disappointed.

FDA delays approval decision for Filspari in rare kidney disease FSGS until April 2026. Travere Therapeutics (TVTX) continues commercial preparations for potential first FSGS treatment.

FILSPARI (sparsentan) for rare kidney disease FSGS is close to FDA approval, with no advisory committee needed! It's the 1st potential treatment, showing strong trial results by reducing protein in ur...

Shrugging off an earlier phase 3 disappointment, Travere’s Filspari has become the first FDA-approved treatment for rare kidney disease FSGS.

How a rare disease drugmaker won FDA approval after a clinical trial disappointed.

Sparsentan, sold as Filspari, will be available for nephrologists to prescribe immediately to patients with FSGS

FDA extends review of Travere's Filspari for focal segmental glomerulosclerosis by three months to April 13, after company submitted new responses on clinical benefit

Plus, news about Eli Lilly and Cognition Therapeutics.

FILSPARI indicated to reduce proteinuria in adults and children aged 8 years and older with FSGS who do not have nephrotic syndrome Additional indication for FILSPARI expands total addressable populat...

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Ligand (Nasdaq: LGND) said partner Travere Therapeutics received full FDA approval on April 14, 2026 for FILSPARI (sparsentan) to reduce proteinuria in adults and children aged 8+ with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. Ligand is entitled to a 9% royalty on worldwide net sales. In Travere’s Phase 3 DUPLEX trial, FILSPARI cut proteinuria by 48% vs 27% for irbesartan in non‑nephrotic patients at Week 108 and showed a 1.1 mL/min/1.73 m2 eGFR benefit.

Travere Therapeutics (Nasdaq: TVTX) said the FDA extended review of its supplemental NDA for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS), setting a new PDUFA target action date of April 13, 2026.The FDA deemed Travere's recent responses to requests for further characterization of clinical benefit a Major Amendment, which triggered the extension. No additional safety or manufacturing information was requested. Travere says commercial launch preparations continue in parallel. FILSPARI is already approved by the FDA and EMA for slowing kidney function decline in adults with IgA nephropathy.

Pegtibatinase maintained 53.5% homocysteine and 67.1% methionine reductions over 50 weeks in classical HCU patients. Phase 3 HARMONY study enrollment to restart in 2026.

Strong Q2 performance drives Travere's growth with FILSPARI sales reaching $71.9M. See full financial results and pipeline updates for FSGS approval timeline.

Ligand Pharmaceuticals (LGND) reported strong Q1 2025 financial results with total revenues of $45.3 million, up 46% from Q1 2024. Portfolio royalty revenue grew 44% to $27.5 million, driven by Recordati's Qarziba and Travere's Filspari. However, the company posted a GAAP net loss of $42.5 million ($2.21 per share), compared to net income of $86.1 million in Q1 2024. Core adjusted net income was $26.6 million ($1.33 per diluted share). The company reaffirmed its 2025 guidance with expected total revenue of $180-200 million and adjusted EPS of $6.00-$6.25. Key strategic moves include a merger agreement with Channel Therapeutics for ZELSUVMI commercialization and a $50 million royalty investment in Castle Creek Biosciences' D-Fi Phase 3 study.

Travere advances FILSPARI towards potential first-ever FSGS treatment following FDA meeting. Phase 3 data shows promising results for rare kidney disorder.