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Investing.com - H.C. Wainwright has reiterated its Buy rating and $47.00 price target on Travere Therapeutics (NASDAQ:TVTX), which has seen its stock surge 68.54% over the past year and is currently trading near its 52-week high at $27.47. The firm cites the company’s adapted REMS (Risk Evaluation and Mitigation Strategy) as a competitive advantage. According to InvestingPro data, analysts maintain a strong buy consensus with targets ranging from $20 to $47.
The research firm views the reduced REMS requirements for FILSPARI as positive news for Travere, particularly as it competes with Novartis (NYSE:NVS) Vanrafia (atrasentan), which received accelerated approval for IgAN in April 2025 without a REMS.
FILSPARI’s reduced REMS removes a logistical burden for both patients and prescribers, potentially providing the drug with a competitive advantage in IgAN, a chronic condition where ease of use, adherence, and long-term safety are key considerations.
H.C. Wainwright notes that FILSPARI launched in the U.S. in the first quarter of 2023, benefiting from early market entry and increasing physician familiarity with the treatment.
The firm believes Travere has executed well commercially despite the previous REMS requirements and expects prescriber willingness to adopt FILSPARI to increase further now that these requirements have been removed.
In other recent news, Travere Therapeutics announced that the FDA no longer requires an advisory committee meeting for its supplemental New Drug Application (sNDA) for Filspari in treating focal segmental glomerulosclerosis (FSGS). The Prescription Drug User Fee Act (PDUFA) date for a regulatory decision remains set for January 13, 2026. This development follows the FDA’s initial acceptance of the sNDA with a standard review, which initially included expectations for an advisory committee meeting. Jefferies reiterated a Buy rating with a $35 target, viewing the cancellation of the advisory committee as a positive sign of FDA support for the use of UPCR as a primary endpoint for full approval in FSGS. Cantor Fitzgerald also reiterated an Overweight rating on Travere shares after the announcement. Additionally, Travere maintained its Buy rating and a $47 price target from H.C. Wainwright following the presentation of new long-term data on pegtibatinase. This data, from the Phase 1/2 COMPOSE open-label extension study, showed significant reductions in total homocysteine and methionine for patients with classical homocystinuria. These recent developments have been notable for Travere Therapeutics.
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