Travere Therapeutics stock surged Friday after the biotech company snagged full Food and Drug Administration approval for its kidney disease treatment, Filspari.
Previously, Filspari had an accelerated approval to treat patients with IgA nephropathy. In this disease, antibodies called IgA build up in kidney tissue, causing damage. Under the previous approval, doctors could use Filspari in the roughly 30,000 to 50,000 patients at risk for "rapid progression" of their disease. The FDA removed that requirement, expanding the market to north of 70,000 IgA patients in the U.S.
Wedbush analyst Laura Chico says this brings peak sales estimates for Filspari up to $661 million from her previous view for $545 million.
On today's stock market, Travere Therapeutics shares shot up 10.6% to close at 10.98.
Travere Therapeutics Follows Calliditas' Steps
Leerink Partners analyst Joseph Schwartz said the outcome was in line with his optimistic expectations. He noted Travere's rival Calliditas Therapeutics won full FDA approval for its IgA nephropathy drug, Tarpeyo, in December 2023. Similarly, the agency removed the "rapid progression" requirement.
Travere Therapeutics' drug is still under a Risk Evaluation and Mitigation Strategy, or REMS, program. Doctors must monitor patients' liver enzymes before starting treatment, every month for the first year and then every three months during treatment.
"As we noted ahead of the (approval decision date), there was no precedent for the REMS to be removed at this early juncture and our base case was for no relaxation of monitoring requirements yet," Schwartz said in his report.
But Travere is planning to eventually ask the FDA to remove that requirement.
"We think the launch of Filspari is positioned well for additional growth in the second half of 2024 and beyond," Schwartz said.
He reiterated his outperform rating and 20 price target on Travere Therapeutics stock.
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