We came across a bullish thesis on Travere Therapeutics, Inc. on HalfBakedInnovations’s Substack by Biotech Distilled. In this article, we will summarize the bulls’ thesis on TVTX. Travere Therapeutics, Inc.'s share was trading at $30.07 as of February 9th. TVTX’s forward P/E was 26.32 respectively according to Yahoo Finance. 7 Best Dialysis and Kidney Disease Stocks to Buy yezry/Shutterstock.com Travere Therapeutics (TVTX) is a biotech company focused on rare kidney and metabolic diseases, with its lea ...

We came across a bullish thesis on Travere Therapeutics, Inc. on HalfBakedInnovations’s Substack by Biotech Distilled. In this article, we will summarize the bulls’ thesis on TVTX. Travere Therapeutics, Inc.'s share was trading at $30.07 as of February 9th. TVTX’s forward P/E was 26.32 respectively according to Yahoo Finance. 7 Best Dialysis and Kidney Disease Stocks to Buy yezry/Shutterstock.com Travere Therapeutics (TVTX) is a biotech company focused on rare kidney and metabolic diseases, with its lea ...

Travere Therapeutics Corporate Overview February 2026 Forward-Looking Statements This presentation contains forward-looking statements, including but not limited to statements about: continued progress with the FILSPARI launch in IgAN; statements regarding our products and products in development as potential foundational treatments and/or treatment standards; additional development and regulatory milestones, including expected data from additional studies and the expected timing thereof; plans and expectat ...

Company Overview - Travere Therapeutics is a San Diego-based biopharmaceutical company focused on rare kidney and metabolic diseases [1] - The company's key product, FILSPARI (sparsentan), is fully approved for IgA Nephropathy (IgAN) [1] Product Pipeline - FILSPARI is expected to receive a PDUFA decision on January 13, 2026, for its application in treating focal segmental glomerulosclerosis (FSGS) [1]

Core Viewpoint - Travere Therapeutics Inc. is considered one of the best mid-cap growth stocks to buy, despite a recent delay in FDA approval for its drug Filspari, with a positive long-term outlook for approval [1][3]. Group 1: FDA Review and Approval Process - The FDA has extended the review period for Travere's supplemental New Drug Application for Filspari, with a new action date set for April 13 [2][3]. - The extension was due to Travere's submission of additional data requested by the FDA to better define the clinical benefits of Filspari, classified as a Major Amendment [3]. - The FDA has not requested further information regarding the safety or manufacturing of Filspari, indicating a focus on clinical data evaluation [3]. Group 2: Market Analysis and Investment Outlook - Bank of America has lowered its price target for Travere Therapeutics from $47 to $43 while maintaining a Buy rating, reflecting confidence in the company's potential despite the delay [1]. - The overall outlook for Filspari's approval remains positive, as the delay is seen as a temporary setback rather than a fundamental issue with the drug [1]. Group 3: Company Overview - Travere Therapeutics is a biopharmaceutical company focused on developing therapies for rare kidney and metabolic diseases in the US [4].

Core Insights - Travere Therapeutics anticipates approximately $127 million in U.S. net product sales for Q4 2025 and around $410 million for the fiscal year 2025, ending the year with about $323 million in cash and equivalents [1][6][7] Corporate Update - The company reported a record number of patients treated with FILSPARI for IgA Nephropathy (IgAN), emphasizing its foundational role in therapy [2] - Travere is preparing for the potential commercial launch of FILSPARI in Focal Segmental Glomerulosclerosis (FSGS), which would be the first approved medication for this condition [2][6] - The pivotal Phase 3 HARMONY Study of pegtibatinase is set to restart in Q1 2026 following manufacturing optimizations [5] Financial Performance - Preliminary U.S. net product sales of FILSPARI reached approximately $103 million in Q4 2025, marking a 108% year-over-year growth, with total sales for 2025 around $322 million [6] - The company received a $40 million milestone payment from CSL Vifor for market access achievements, with FILSPARI launched in several European countries [6] Regulatory and Development Milestones - The PDUFA target action date for the supplemental New Drug Application (sNDA) for FILSPARI in FSGS is set for January 13, 2026 [6] - The company is generating clinical evidence to support FILSPARI's role in IgAN through ongoing studies and presentations at medical meetings [6] - Chugai Pharmaceutical plans to submit a New Drug Application for sparsentan in Japan in 2026, with Travere eligible for additional milestone payments [6]

Travere Therapeutics Corporate Overview January 2026 Forward-Looking Statements This presentation contains forward-looking statements, including but not limited to statements about: continued progress with the FILSPARI launch in IgAN; statements regarding our products and products in development as potential foundational treatments and/or treatment standards; additional development and regulatory milestones, including expected data from additional studies and the expected timing thereof; plans and expectati ...

Core Insights - Travere Therapeutics announced late-breaking data from the Phase 3 DUPLEX Study, showing that FILSPARI (sparsentan) significantly improved proteinuria outcomes in patients with focal segmental glomerulosclerosis (FSGS) compared to irbesartan [1][2][3] Study Findings - In the DUPLEX Study, 37.5% of patients treated with FILSPARI achieved a urine protein-to-creatinine ratio (UPCR) below 0.7 g/g, compared to 21.4% for those on irbesartan, indicating a relative risk (RR) of 1.8 [3] - At week 108, 19% of FILSPARI-treated patients reached the UPCR threshold versus 11.2% for irbesartan, with an RR of 1.7 [3] - Patients achieving UPCR below 0.7 g/g had a lower likelihood of reaching kidney failure (3.6% vs. 11.2%, RR 0.52) [3][4] Long-term Risk Analysis - In the DUPLEX-aligned RaDaR cohort, achieving UPCR below 0.7 g/g at 24 months was linked to a significantly lower risk of kidney failure over an additional 60 months (hazard ratio [HR] 0.14) [4] - A similar lower risk was observed for patients who achieved UPCR below 0.7 g/g at any time during the 24-month period (HR 0.27) [4] - The analysis indicated that a 26% relative reduction in UPCR for FILSPARI-treated patients correlates to a 24% reduction in the 5-year risk of kidney failure (HR 0.76) [8] Background on FSGS - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S., characterized by progressive scarring and often leading to kidney failure [7] - There are currently no FDA-approved pharmacologic therapies specifically for FSGS [7] Company Overview - Travere Therapeutics is focused on developing therapies for rare diseases, with FILSPARI currently indicated for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) [9][28]

FILSPARI in IgAN - FILSPARI is positioned to replace the historical standard of care in IgAN, supported by the 2025 KDIGO guidelines for earlier, first-line use in patients at risk of progression [13, 127] - In the U S, there are over 70,000 addressable patients with IgAN for FILSPARI [8, 15, 34, 38, 74] - FILSPARI demonstrated approximately 40% reduction in proteinuria after 110 weeks in the PROTECT study, with ~3x greater complete remission compared to irbesartan [48, 49] - FILSPARI treatment may potentially delay dialysis or transplant by 4 5 years compared to irbesartan [57] - U S net FILSPARI sales reached approximately $91 million in 3Q25, representing approximately 155% growth versus 3Q24 [32] FILSPARI in FSGS - There are up to 30,000 potential addressable patients with FSGS in the U S [8, 77] - In the DUPLEX study, sparsentan resulted in approximately 50% reduction in proteinuria [86] - Patients treated with sparsentan achieved approximately 1 6x greater partial remission compared to irbesartan [91] - The PDUFA target action date for FILSPARI in FSGS is January 13, 2026 [10, 13, 88] Pegtibatinase in HCU - Pegtibatinase has the potential to become the only disease-modifying treatment for classical HCU [13, 106, 127] - In the COMPOSE study, the highest dose cohort of pegtibatinase achieved a ~67% mean relative reduction in total homocysteine from baseline [111, 119]

FILSPARI (sparsentan) for IgAN - FILSPARI is positioned as a foundational treatment for IgAN, targeting kidney injury by blocking ET-1 and ANG-II, with >70,000 addressable patients in the U S [9, 10, 22, 32, 64] - Clinical trials showed FILSPARI resulted in ~40% reduction in proteinuria after 110 weeks compared to irbesartan [43] - SPARTAN study showed ~70% reduction in proteinuria from baseline at week 24 in newly diagnosed patients [56] - U S commercial launch of FILSPARI outperformed benchmark launches, with ~$132 million in net sales in FY24, a ~78% growth over 2023 [61, 110] Sparsentan for FSGS - Travere plans to submit an sNDA for sparsentan in FSGS around the end of 1Q25 [11, 14] - DUPLEX study showed sparsentan resulted in a ~50% reduction in proteinuria [79] - DUPLEX study showed ~2 5x greater complete remission with sparsentan compared to irbesartan [84] - There are 15,000-30,000 potential addressable patients with FSGS in the U S [10, 70] Pegtibatinase for HCU - Pegtibatinase is a potential disease-modifying therapy for classical HCU, targeting the underlying genetic cause [14, 88, 95] - Phase 1/2 COMPOSE study showed a ~67% mean relative reduction in total homocysteine (tHcy) from baseline in the highest dose cohort [99, 106] - The company is on track to restart enrollment in the Phase 3 HARMONY Study in 2026 [14, 108]