The Food and Drug Administration accepted Travere Therapeutics' application for a kidney disease treatment on Monday, leading TVTX stock to surge.
The FDA assigned a speedier priority review to Travere's sparsentan in patients with IgA nephrology, also known as Berger's disease. In this disease, a protein builds up in the kidneys, causing problems with their normal filtering mechanism. This leads to blood and protein in the urine. The speedier FDA review means Travere could launch sparsentan before year-end.
"Sparsentan has a long development history, and today's announcement brings the asset one step closer to commercialization," SVB Securities analyst Joseph Schwartz said in a report to clients.
On today's stock market, TVTX stock popped 6.1% to 23.54.
TVTX Stock: Interim Study Promising
In an interim look at its pivotal study, sparsentan reduced the level of protein in patients' urine by an average 49.8% after 36 weeks. A standard drug led to a 15.1% reduction.
The study is ongoing with final results due in the second half of 2023. The final results will examine a marker of kidney disease known as estimated glomerular filtration rate, or eGFR. But the FDA could approve sparsentan earlier based on its ability to lower protein in the urine. The latter measurement could act as confirmation of sparsentan's benefit for patients.
"We are encouraged to see the FDA has designated the (application) with priority review, as this will shorten the review time from 10 months to approximately six months, potentially allowing sparsentan to hit the market by the end of the year," SVB Securities' Schwartz said.
He sees sparsentan hitting peak sales of $1.4 billion for this use. Travere also is testing the drug in patients with another kidney disease known as focal segmental glomerulosclerosis, or FSGS. Schwartz retained his outperform rating on TVTX stock.
Additional Testing Questioned
Laura Chico, a Wedbush analyst, says the test results aren't as robust in FSGS patients. But Travere will have additional results in this disease later this quarter.
Positive results could prod Travere to ask the FDA for an accelerated filing, also based on the drug's ability to lower protein in the urine.
"The overall data in the space supporting (protein in the urine) as a surrogate measure in IgA nephrology appears more mature in our view vs. data in FSGS," Chico said in her note to clients. "With this in mind, we believe there will be a high bar in FSGS."
Chico kept her neutral rating and 24 price target on TVTX stock.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
