TVTX Stock Falls as FDA Extends Review Timeline for Filspari sNDA

Shares of Travere Therapeutics TVTX were down 14.6% on Tuesday after the company announced that the FDA had extended the review timeline for the supplemental new drug application (sNDA) seeking label expansion for its marketed drug, Filspari (sparsentan), in the focal segmental glomerulosclerosis (FSGS) indication by an additional three months.

A final decision from the regulatory body is now expected on April 13, 2026.

The extension comes after the company submitted additional information requested by the FDA to better define the clinical benefit of Filspari. The FDA classified these submissions as a major amendment to the sNDA and therefore extended the review timeline from Jan. 13, 2026, to April 13, 2026. The regulatory body, however, did not request any new safety or manufacturing data for Filspari.

Filspari is currently approved to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression.

TVTX’s Price Performance

In the past six months, shares of Travere Therapeutics have surged 72.1% compared with the industry’s increase of 20.4%.

More on the FDA Review Extension for TVTX’s Filspari sNDA

FSGS is a rare kidney disorder affecting more than 40,000 patients in the United States and a comparable number in the European Union. The disease is marked by progressive kidney scarring and proteinuria (protein in the urine), where leaked protein damages kidney structures and drives disease progression. Patients often experience edema, low blood albumin, abnormal lipid levels and hypertension, with many ultimately progressing to kidney failure. Currently, there are no FDA-approved treatments for FSGS.

A potential FDA nod to Filspari in FSGS will make the drug the first medication to be indicated for the given indication. The drug is an oral, non-immunosuppressive potential therapy designed to address podocyte injury, a critical factor in the progression of FSGS.

If Filspari is approved for FSGS indication, Travere Therapeutics will be well-positioned for a successful commercial launch.

TVTX Post Preliminary Revenues for 2025

Earlier this week, Travere Therapeutics reported preliminary sales numbers for the fourth quarter and full-year 2025. The company expects total net product sales of about $127 million in the fourth quarter of 2025 and approximately $410 million for full-year 2025 in the United States.

Preliminary U.S. net product sales of Filspari were around $103 million in the fourth quarter of 2025, reflecting an increase of 108% year over year. For full-year 2025, preliminary U.S. net product sales of Filspari were approximately $322 million.

In October 2025, the company received a $40 million milestone payment from its partner, CSL Vifor, after achieving market access milestones. CSL Vifor has launched Filspari in Germany, Austria, Switzerland, Luxembourg, and the United Kingdom, and Travere Therapeutics is entitled to receive further milestone payments tied to additional market access and sales.

Travere Therapeutics plans to continue building clinical evidence to support Filspari as a foundational treatment for IgAN through ongoing clinical studies. Also, the potential label expansion for Filspari in the FSGS indication is likely to aid sales further in 2026.

Travere Therapeutics, Inc. Price

Travere Therapeutics, Inc. price | Travere Therapeutics, Inc. Quote

TVTX's Zacks Rank & Stocks to Consider

Travere Therapeutics currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Keros Therapeutics KROS, Krystal Biotech KRYS and Immunocore IMCR, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2026 loss per share estimates for Keros Therapeutics have narrowed from $3.65 to $3.47. In the past six months, shares of KROS have risen 33.8%.

Keros Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the mark on one occasion. On average, the company delivered a surprise of 9,098.63%.

In the past 60 days, estimates for Krystal Biotech’s 2026 earnings per share have moved up from $8.34 to $8.46. KRYS stock has surged 94.2% in the past six months.

Krystal Biotech’s earnings beat estimates in three of the trailing four quarters, while missing the mark on one occasion. On average, the company delivered a surprise of 40.43%.

In the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from $1.18 to 90 cents. In the past six months, shares of IMCR have lost 8.5%.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the mark on one occasion. On average, the company delivered a surprise of 53.96%.

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