Travere Therapeutics shares advanced Thursday, coming within striking distance of a breakout, after the Food and Drug Administration altered monitoring requirements for its drug, Filspari.
Filspari treats IgA nephropathy, a disease that causes inflammation and damage that can lead to kidney failure. When Filspari won full approval in 2024, the FDA added a Risk Evaluation and Mitigation Strategy, or REMS, to the label. This required monitoring patients for liver function.
Now, the FDA has relaxed that requirement. Patients need to undergo quarterly liver function tests, as opposed to monthly. The agency also removed the requirement that pregnant patients be monitored for toxicity to the developing embryo or fetus.
Leerink Partners analyst Joseph Schwartz noted the monitoring requirement hadn't slowed Filspari's launch. Filspari generated $132.2 million in sales last year. This year, analysts polled by FactSet call for $321.9 million in sales, up more than 143%.
"However, we are encouraged by the loosening of the REMS, which we think could incrementally open up the addressable patient population and provide a nice tailwind to the ongoing launch in IgAN," Smith said in a report to clients.
Travere Therapeutics stock rose 1.5% to 17.70, paring back from steeper gains. Shares are flirting with a buy point at 19.08 out of a cup-with-handle base, according to MarketSurge.
Travere Therapeutics Eyes Another Approval
Smith notes the new monitoring requirement is consistent with how Travere ran its clinical testing.
Wedbush analyst Laura Chico said anything that makes prescribing easier is a plus.
"Our prior physician survey work did not find the prior Filspari REMS program to be a significant impediment to prescribing," she said in a report. "Nevertheless, we anticipate the quarterly cadence for liver function monitoring should be less cumbersome over the long run for patients and should sync up with office visits."
The analysts note Travere Therapeutics is trying to win approval for Filspari to treat focal segmental glomerulosclerosis, or FSGS. In this condition scar tissue develops on glomeruli, the part of the kidneys that filters waste from the blood. The FDA is due to hold an advisory committee meeting in the fourth quarter to discuss the risks and benefits of Filspari for this use. Potential approval is on Jan. 13.
Chico and Smith kept their outperform ratings on Travere stock.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
