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On Friday, Stifel analysts maintained their Hold rating on shares of Travere Therapeutics (NASDAQ:TVTX), which has seen its stock surge over 216% in the past year, following the news that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Sparsentan in the treatment of FSGS, a rare kidney disorder. According to InvestingPro data, six analysts have recently revised their earnings expectations upward for the upcoming period, suggesting growing confidence in the company’s prospects despite current valuation levels indicating the stock is fairly valued. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 13, 2026, for its review, which indicates a standard review process rather than the expedited priority review that the company had anticipated.
The analysts noted that this development is a setback for Travere, as management had previously expressed hopes for a priority review and a possible product launch in 2025. The expectation of a standard review timeline delays the potential market introduction of Sparsentan to the following year, which diverges from what the market was expecting. Despite these challenges, the company maintains a strong financial position with a current ratio of 2.05, indicating sufficient liquid assets to meet short-term obligations, and has achieved impressive revenue growth of 75.65% over the last twelve months.
The possibility of an advisory committee (adcom) meeting to discuss the Sparsentan data is also on the horizon, though it was noted that such a meeting would not be surprising. This is due to the potentially precedent-setting nature of an approval for Sparsentan, which is based largely on proteinuria findings as opposed to eGFR—a measure of kidney function.
The Stifel analysts remarked that while the FDA’s acceptance of the sNDA is an important step towards potential approval, the delayed timeline is a disappointment relative to market expectations for a swift, narrative-changing launch that was anticipated to begin later this year.
The PARASOL trial findings, which were discussed last fall, support Sparsentan’s application. The analysts expect that a specific discussion of the data related to Sparsentan’s use in treating FSGS during the potential adcom meeting would provide valuable insights into its efficacy and safety. With analyst price targets ranging from $22 to $47, investors seeking deeper insights into Travere’s potential can access comprehensive analysis through InvestingPro’s detailed research reports, which offer exclusive financial metrics and expert analysis for over 1,400 US stocks.
In other recent news, Travere Therapeutics reported its first-quarter 2025 earnings, exceeding analyst expectations with an earnings per share (EPS) of -$0.19 against the forecasted -$0.55, and revenue of $81.7 million surpassing the expected $78.05 million. The company’s flagship product, FILSPARI, contributed significantly to this performance, with net sales of $55.9 million, marking a 182% increase compared to the previous year. Additionally, Travere announced that the FDA accepted its supplemental New Drug Application (sNDA) for FILSPARI, aiming for traditional approval as a treatment for focal segmental glomerulosclerosis (FSGS), with a target action date set for January 13, 2026.
Citi analysts reiterated a Buy rating on Travere stock with a $35 price target, expressing confidence in the potential of sparsentan despite the FDA’s decision to opt for a standard review timeline, which is longer than anticipated. Cantor Fitzgerald also maintained an Overweight rating on Travere, highlighting investor optimism about the company’s prospects in treating FSGS. The FDA’s decision to hold an advisory committee meeting for FILSPARI reflects a meticulous approach to the approval process, consistent with practices for novel treatments.
Travere’s progress in developing a treatment for FSGS, a rare kidney disorder, has been closely watched by investors, as FILSPARI could become the first FDA-approved medication for this condition. The company’s ongoing efforts to expand treatment options for rare kidney disorders come amid a successful commercial launch of FILSPARI in IgA nephropathy. These developments underscore Travere’s commitment to addressing unmet medical needs in rare diseases, while analysts and investors continue to monitor the regulatory process and potential market impact.
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