ST. GALLEN, Switzerland, and SAN DIEGO, Sept. 26, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) support the recent publication of the updated clinical practice guidelines for the treatment of IgA Nephropathy (IgAN), Kidney Disease: Improving Global Outcomes (KDIGO) 2025 clinical practice guideline for the management of IgA Nephropathy and Immunoglobulin A vasculitis. The updated guidelines define diagnostic criteria, treatment goals and treatment approaches, aiming for progre ...

Core Viewpoint - The article initiates coverage on Travere Therapeutics, Inc. (NASDAQ: TVTX) with a Buy Rating, highlighting the significant potential of its drug sparsentan [2] Company Overview - Travere Therapeutics is positioned in the pharmaceutical sector, focusing on innovative treatments [2] - The company is noted for its drug sparsentan, which is expected to have a substantial impact in its therapeutic area [2] Investment Analysis - The analysis suggests that Travere Therapeutics has a promising outlook due to the potential of sparsentan [2] - The article emphasizes the importance of deep-dive analysis in making informed investment decisions within the biotech sector [2]

Core Viewpoint - The article initiates coverage on Travere Therapeutics, Inc. (NASDAQ: TVTX) with a Buy Rating, highlighting the significant potential of its drug sparsentan [2]. Company Overview - Travere Therapeutics is positioned in the pharmaceutical sector, focusing on innovative treatments, particularly with its lead drug sparsentan [2]. Investment Potential - The analysis emphasizes the massive potential of sparsentan, suggesting that it could be a key driver for the company's growth and stock performance [2].

Core Insights - Travere Therapeutics (TVTX) received an encouraging update from the FDA regarding its supplemental new drug application (sNDA) for Filspari (sparsentan) in treating focal segmental glomerulosclerosis (FSGS), with a final decision expected on January 13, 2026, leading to a 26.2% increase in TVTX's shares [1][6] Company Overview - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S. and a similar number in the EU, characterized by kidney scarring and proteinuria, which can lead to kidney failure [2] - Filspari, if approved, would be the first treatment specifically indicated for FSGS, designed to address podocyte injury, a key factor in the disease's progression [3] Clinical Evidence - The sNDA for Filspari is supported by robust clinical data from the phase III DUPLEX and phase II DUET studies, showing significant reductions in proteinuria compared to Sanofi's Avapro [4][9] - The DUPLEX study demonstrated a 67% to 77% lower risk of kidney failure for patients achieving remission, although it did not meet the primary efficacy endpoint for eGFR slope [8][9] Market Performance - Year-to-date, TVTX stock has increased by 56.8%, significantly outperforming the industry average growth of 4.9% [5] Regulatory Developments - Filspari was previously granted full approval for IgA nephropathy (IgAN), making it the only non-immunosuppressive medication in that space [10] - The FDA recently streamlined the Risk Evaluation and Mitigation Strategies (REMS) for Filspari, reducing monitoring burdens and potentially accelerating physician adoption [13]

Core Insights - Travere Therapeutics, Inc. (NASDAQ:TVTX) reached an all-time high on Wednesday following the FDA's decision to cancel the creation of an advisory committee for its drug application to treat focal segmental glomerulosclerosis (FSGS) [1][3] - The stock price peaked at $28.69 during the session, ultimately closing up 26.2% at $27.31 [2] - The FDA's decision indicates reduced concerns regarding the drug candidate, Filspari, which aims to be the first treatment for FSGS, a major cause of kidney failure [3] Company Developments - Travere Therapeutics is optimistic about the progress of its supplemental New Drug Application (sNDA) for Filspari and is preparing for a commercial launch expected by January 2026 [4] - Filspari is characterized as an oral, non-immunosuppressive therapy targeting podocyte injury, a significant factor in the progression of FSGS [4] - The CEO of Travere Therapeutics emphasized the urgent need for approved therapies for FSGS, highlighting the long wait patients have endured for treatment options [5]

Company Overview - Travere Therapeutics (TVTX) shares increased by 26.2% to close at $27.31, with trading volume significantly higher than usual, and a 24.3% gain over the past four weeks [1][2] Drug Development and FDA Approval - The surge in Travere's stock was driven by the FDA's announcement that no advisory committee review is needed for its Filspari supplemental new drug application for focal segmental glomerulosclerosis, with a decision expected in January 2026 [2] - If approved, Filspari would be the first treatment specifically for this rare kidney disease, supported by strong clinical data indicating significant proteinuria reduction and lower kidney failure risk [2] - Filspari is already approved for IgA nephropathy and has recently gained a streamlined safety program, enhancing its potential for adoption [2] Financial Performance Expectations - Travere is projected to report a quarterly loss of $0.32 per share, reflecting a year-over-year increase of 54.3%, with expected revenues of $102.15 million, up 62.4% from the same quarter last year [3] - The consensus EPS estimate for the quarter has been revised marginally lower over the last 30 days, indicating a negative trend in earnings estimate revisions, which typically does not lead to price appreciation [4] Industry Context - Travere operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Regeneron (REGN), closed at $555.83, showing a slight decline of 0.1% in the last trading session [4] - Regeneron's consensus EPS estimate has decreased by 0.8% over the past month to $9.46, representing a 24.1% decline from the previous year [5]

Group 1 - The article discusses the performance and outlook of Travere Therapeutics, Inc. (NASDAQ: TVTX), highlighting its recent approval for the therapy Filspari (sparsentan) [1] - The author provides insights into the biotech, pharma, and healthcare industries, emphasizing the importance of understanding key trends and catalysts that drive valuations [1] - The investing group Haggerston BioHealth offers resources for both novice and experienced biotech investors, including product sales forecasts and market analysis [1] Group 2 - The article is authored by a biotech consultant with over five years of experience in the industry, who has prepared detailed reports on more than 1,000 companies [1] - The focus is on providing buy and sell ratings, as well as financial analyses such as discounted cash flow analysis [1]

Core Viewpoint - The FDA's decision to eliminate a key advisory committee meeting for Travere Therapeutics' drug Filspari is seen as a positive indicator for its approval in treating focal segmental glomerulosclerosis (FSGS), a kidney disease with high unmet medical needs [1][4]. Company Summary - Travere Therapeutics' stock surged 18% to $25.52 following the FDA's announcement, positioning it for a nearly three-year high in premarket trading [4]. - The company’s stock has a strong IBD Digital Composite Rating of 96, indicating it outperforms 96% of all stocks based on fundamental and technical measures [5]. Industry Summary - Filspari is already approved for treating IgA nephropathy (IgAN) and would be the first drug approved for FSGS based on evidence of reducing proteinuria [2][3]. - The advisory committee typically assesses the benefits and risks of drugs before recommending FDA approval, but the cancellation of this meeting suggests confidence in the drug's efficacy and safety [3][4].

Group 1 - Travere Therapeutics (NASDAQ:TVTX) experienced a ~27% increase in premarket trading on Wednesday [4] - The company received notification from the FDA that an advisory committee meeting will not be required for the review of a potential label expansion for its kidney treatment [4]

Core Viewpoint - Travere Therapeutics, Inc. announced that the FDA has informed the company that an advisory committee is no longer needed for the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS) [1] Group 1 - The sNDA for FILSPARI® remains under review by the FDA [1] - The Prescription Drug User Fee Act (PDUFA) target action date is set for January 13, 2026 [1]