Travere Therapeutics stock popped to a 16-month high Wednesday after a group of experts suggested an alternative means of measuring the success of treatments for a kidney disease.
The biotech company is working on a treatment for focal segmental glomerulosclerosis, or FSGS. In this condition, the kidney's filtering units become scarred or hardened. This leads to protein in the urine — called proteinuria — kidney failure and other complications.
Typically, FSGS treatments must show improvement in estimated glomerular filtration rate, or eGFR. This is a measurement of how well the kidneys are working based on a blood test and factors like age, sex and body type. But lowering proteinuria levels could be a better gauge of how well treatments for FSGS are working, experts said at a meeting in Bethesda, Md.
The group didn't vote on the matter, but the Food and Drug Administration seems open to the idea of updating the goals for studies of FSGS treatments, Wedbush analyst Laura Chico said in a report.
"FDA acknowledged the need to pivot in FSGS and confidently anticipates new endpoints (study goals) will emerge," she said. "We do think this could include proteinuria as a validated surrogate endpoint to support full approval."
Travere Therapeutics stock jumped 15.7% to 17.59. At one point, shares hit their highest level since June 2023.
Travere Therapeutics Could Expand Filspari
Travere Therapeutics is testing its drug, sparsentan, in patients with FSGS. The same drug is already approved for patients with immunoglobulin A nephropathy, a disease that causes kidney inflammation over time. It sells under the brand name Filspari.
"While we caveat this is the first step in the process, we do look for Travere Therapeutics to seek an FDA meeting to pursue a potential supplemental new drug application filing for Filspari," Chico said. "Assuming this occurs in the first half of 2025, approval could arrive by late 2025."
She raised her price target on Travere stock to 25 from 17, and kept her outperform rating. She expects Travere Therapeutics to launch Filspari in FSGS treatment in late 2025 and projects $383 million in 2030 sales.
"Should an approval manifest, there is also likely potential (mergers and acquisitions) value for Travere Therapeutics," she said.
Travere Therapeutics shares have a nearly perfect IBD Digital Relative Strength Rating of 98. This means they rank in the top 2% of all stocks when it comes to 12-month performance.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
