Travere Therapeutics Delivers Over 180% Gain In 6 Months

Travere Thereapeutics

18.97 USD -2.32%

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(RTTNews) - For Travere Therapeutics Inc. (TVTX), the year so far has been nothing short of remarkable, with its shares hitting new highs, driven by the success of its oral kidney disease drug, Filspari.

Filspari indicated to slow kidney function decline in adults with a kidney disease called primary immunoglobulin A nephropathy, who are at risk of their disease getting worse, has been on the U.S. market since February 2023. The drug, which was approved under the accelerated approval pathway, was given full FDA approval last September. The drug is also marketed in Europe for the treatment of IgAN by the company's partner CSL Vifor.

IgA nephropathy (IgAN) is the most prevalent primary glomerulonephritis worldwide, often leading to progressive kidney damage if left uncontrolled. This chronic condition is a major cause of kidney failure, with more than 70,000 addressable IgAN patients in the U.S. alone.

Filspari's sales have grown steadily over the quarters, as illustrated in the tables below.

2023

2024

*The Q4 figure represents a preliminary sales estimate. The company is scheduled to report its fourth-quarter and full-year 2024 financial results this month.

The net product sales of Filspari for the full year 2024 are estimated to be $132 million.

In a bid to ease access for certain patients, the company has requested modification of liver monitoring for Filspari in IgAN, and a decision is due on August 28, 2025.

Travere is not only focused on solidifying Filspari's position as the cornerstone treatment for IgA nephropathy (IgAN) but also expanding its potential across a broader range of indications.

Another indication for which Filspari is being explored is focal segmental glomerulosclerosis (FSGS), a kidney disease that causes scarring in glomeruli (filters of the kidney). There are an estimated 15,000 to 30,000 potential addressable FSGS patients in the U.S. Currently, no approved therapeutic options exist for the treatment of FSGS.

The company plans to submit a supplemental New Drug Application seeking traditional approval of Filspari for focal segmental glomerulosclerosis around the end of this quarter.

In addition, Travere is advancing Pegtibatinase, the only potentially disease-modifying treatment in clinical development for classical Homocystinuria (HCU), a rare autosomal recessive metabolic disorder.

HCU is caused by mutations in the cystathionine beta-synthase (CBS) gene, resulting in reduced activity of the CBS enzyme. This deficiency leads to a toxic buildup of homocysteine (Hcy) in the body, which can cause various severe health issues if left untreated. The current standard of care involves vitamin B6, a low-protein diet, dietary supplements, and betaine. However, there are no approved treatments that target the underlying genetic cause of this disorder.

The company is on track to restart enrollment in a phase III trial of Pegtibatinase in patients with classical Homocystinuria, dubbed HARMONY, in 2026. Enrollment in the trial was voluntarily paused by the company in September 2024, to allow for necessary process improvements in manufacturing scale-up to support commercial-scale manufacturing of Pegtibatinase.

TVTX was featured on our site on August 14, 2024, when it was trading at $8.91, and again on Sep.5, 2024, when it was trading at $10.15.

The stock touched a 52-week high of $25.29 during intraday trading yesterday, before closing at $23.75.