Citi maintained its Buy rating on shares of Travere Therapeutics (NASDAQ:TVTX) and increased the price target to $23.00, up from the previous target of $14.00. The adjustment follows the U.S. Food and Drug Administration's (FDA) full approval of Travere's drug Filspari, which is anticipated to expand the medication's market size.
The FDA's decision is expected to grow the eligible patient population from an initial estimate of 30,000-50,000 to approximately 70,000. As a result, sales are projected to see a modest increase in FY24, with a more substantial rise anticipated in 2025. The approval was based on the drug's demonstrated ability to better preserve kidney function over the long term compared to the maximally dosed irbesartan in the Phase 3 PROTECT study.
Citi's analysis suggests that Filspari has the potential to become an essential therapy for kidney health, aligning with recent draft guidelines from the Kidney Disease: Improving Global Outcomes (KDIGO). These draft guidelines recommend lower proteinuria thresholds for treatment initiation, which could lead to broader use of Filspari by physicians.
The drug's full approval could also lead to changes in the current Risk Evaluation and Mitigation Strategy (REMS) that involves liver monitoring, as management has indicated a possibility of submitting a modified supplemental New Drug Application (sNDA).
In other recent news, Travere Therapeutics has made significant progress with its treatment FILSPARI, which has gained full FDA approval for the treatment of adult patients with primary Immunoglobulin A nephropathy (IgAN) at risk of disease progression.
This approval follows successful long-term results from the PROTECT Study, demonstrating FILSPARI's effectiveness in slowing the decline of kidney function over two years.
BofA Securities has reaffirmed its Buy rating on Travere Therapeutics, highlighting the company's strategic positioning. This is in light of the recent growth in the second quarter of 2024, driven by the increasing demand for FILSPARI. The company reported FILSPARI sales reaching $27.1 million in Q2, a 37% increase over Q1.
In addition, Travere Therapeutics has reported a solid financial position, with $325.4 million in cash and securities, supporting its operations into 2028. The company is also in discussions with the FDA regarding a potential modification to the liver-monitoring REMS.
These recent developments underscore Travere's ongoing commitment to establishing FILSPARI as a foundational therapy for IgAN. As the company progresses, it anticipates further growth acceleration for FILSPARI following the upcoming PDUFA date for full approval.
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