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]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Travere Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On May 15, 2025, Travere announced that the FDA plans to hold an advisory committee meeting regarding its supplemental New Drug Application for FILSPARI, aimed at treating focal segmental glomerulosclerosis [3] - Following the FDA announcement, Travere's stock price dropped by $4.35, or 20.57%, closing at $16.80 per share on May 16, 2025 [3] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4] - The firm has successfully recovered numerous multimillion-dollar damages for class members over its 85-year history [4]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Travere Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On May 15, 2025, Travere announced that the FDA plans to hold an advisory committee meeting regarding its supplemental New Drug Application for FILSPARI, aimed at treating focal segmental glomerulosclerosis [3] - Following the FDA announcement, Travere's stock price dropped by $4.35 per share, a decline of 20.57%, closing at $16.80 per share on May 16, 2025 [3] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4] - The firm has successfully recovered numerous multimillion-dollar damages awards for class members over its 85-year history [4]

Summary of Travere Therapeutics (TVTX) Conference Call Company Overview - **Company**: Travere Therapeutics - **Focus**: Rare diseases, specifically targeting IgA nephropathy and FSGS (Focal Segmental Glomerulosclerosis) [3][4] Key Programs and Strategic Focus - **Filspari**: Launched for IgA nephropathy, aiming to be the foundational therapy [3] - **FSGS Program**: Supplemental NDA accepted with a PDUFA date of January 13, 2026 [3][5] - **Classical Homocystinuria (HCU)**: Phase three program set to initiate enrollment next year [4] Regulatory Insights - **Advisory Committee (AdCom)**: Requested by the FDA for FSGS; reasons include questions around endpoints and safety [5][6] - **Endpoints**: Proteinuria identified as a valid surrogate endpoint for kidney failure risk, contrary to eGFR [10][11] - **FDA Feedback**: Consistent with previous submissions; focus on phase three results in context of Parasol [12][13] Market Opportunity - **FSGS Patient Population**: Over 30,000 diagnosed patients in the U.S. not on dialysis, facing significant risk of kidney failure [19][20] - **Therapeutic Need**: Current therapies are ineffective for many patients; Filspari shows a consistent benefit in reducing proteinuria by approximately 50% [19][20] - **Rapid Uptake Expected**: Anticipated due to high unmet need and lack of alternative therapies [20][21] Commercial Dynamics - **IgA Nephropathy Launch**: Sustained growth with over 700 new patient start forms per quarter since full approval [25][26] - **Payer Access**: Improved since full approval; broad access expected to continue [36] - **Competitive Landscape**: Atrasentan from Novartis expected to grow the endothelin class, but Filspari maintains a broader indication [27][28][30] Pipeline and Future Plans - **HCU Program**: Enrollment expected to restart next year [50] - **Pipeline Expansion**: Focus on rare renal diseases; disciplined approach to new opportunities [51] - **Cash Position**: $322 million at the end of Q1; runway expected into 2028 and beyond [54] Upcoming Catalysts - **Key Dates**: PDUFA for REMS modification on April 28; advisory committee for FSGS pending [55] - **Market Access Milestones**: Anticipated payments from partners for approvals and commercial milestones [54][55] Additional Insights - **EMA Involvement**: Less than FDA but still engaged; confidence in EU regulatory pathway [15][16] - **Combination Therapy**: Filspari expected to be used in combination with SGLT2s for enhanced efficacy [34][42] This summary encapsulates the critical points discussed during the conference call, highlighting the company's strategic focus, regulatory insights, market opportunities, commercial dynamics, pipeline developments, and upcoming catalysts.

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Travere Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On May 15, 2025, Travere announced that the FDA plans to hold an advisory committee meeting regarding its supplemental New Drug Application for FILSPARI, aimed at treating focal segmental glomerulosclerosis [3] - Following this announcement, Travere's stock price dropped by $4.35, or 20.57%, closing at $16.80 per share on May 16, 2025 [3] Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of Travere for claims related to potential securities fraud [1] - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud [4]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices by Travere Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On May 15, 2025, Travere announced that the FDA plans to hold an advisory committee meeting regarding its supplemental New Drug Application for FILSPARI, aimed at treating focal segmental glomerulosclerosis [2] - Following the FDA announcement, Travere's stock price dropped by $4.35, or 20.57%, closing at $16.80 per share on May 16, 2025 [2] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3]

Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks in recent months [1] - Travere Therapeutics, Inc. (NASDAQ: TVTX) is highlighted for its impressive sales growth in Q1, despite a recent pullback in stock price and a notable reduction in losses [2] - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade ideas and weekly market commentary [2]

Summary of Travere Therapeutics (TVTX) Conference Call Company Overview - **Company**: Travere Therapeutics - **Focus**: Rare diseases, specifically targeting rare kidney diseases (FSGS and IgA nephropathy) and classical homocystinuria (HCU) [2][3] Key Priorities and Developments 1. **Launch of Filspari for IgA Nephropathy**: - Full approval received in September 2024, leading to a significant increase in demand [3] - New treatment guidelines (QADIGO) expected to enhance accessibility and usage [3][4] - Demand growth observed with a 40% increase in new patient starts post-approval [14] 2. **FSGS Therapy Development**: - Submitted supplemental New Drug Application (sNDA) for potential first therapy for FSGS, with expected FDA notification this month [4][11] - Anticipated PDUFA date in September if priority review is granted [4] 3. **HCU Program**: - Reinitiating enrollment in Phase III program following commercial manufacturing scale-up [4] Treatment Landscape - **IgA Nephropathy**: - New therapies are changing patient outcomes, allowing for prolonged kidney function [5] - Filspari shows superiority over traditional RAS inhibitors in improving kidney function and reducing proteinuria [6][8] - Combination therapy is emphasized due to the dual nature of the disease affecting both the immune system and kidneys [7] - **FSGS**: - High unmet need with rapid progression to kidney failure, especially in children [10] - Proteinuria is identified as a key predictor of kidney failure, leading to a shift in regulatory acceptance of proteinuria as an endpoint for clinical trials [12][42] Market Dynamics - **Growth Potential**: - Majority of IgA nephropathy patients have proteinuria levels below 1.5, representing a significant market opportunity [15] - The evolving treatment guidelines are expected to drive earlier and more aggressive interventions [19][20] - **Regulatory Environment**: - FDA is becoming more open to using proteinuria as a clinical trial endpoint, which could facilitate innovation in FSGS treatments [42] Financial Position - **Capitalization**: - Company reported a cash balance of $322 million at the end of the last quarter, positioning it well for future growth initiatives [48] Future Directions - **Pipeline Expansion**: - Interest in developing therapies for other rare diseases, particularly within the rare kidney disease space [48][52] - Focus on building evidence for combination therapies and establishing Filspari as a foundational treatment [28][31] Conclusion - Travere Therapeutics is strategically positioned to capitalize on its recent approvals and ongoing clinical programs, with a strong emphasis on addressing unmet needs in rare kidney diseases. The company is focused on expanding its pipeline and enhancing treatment accessibility while navigating a rapidly evolving regulatory landscape.

Group 1 - Travere Therapeutics reported $81.73 million in revenue for Q1 2025, a year-over-year increase of 97.6% [1] - The EPS for the same period was -$0.47, improving from -$1.76 a year ago, with a surprise of +14.55% compared to the consensus estimate of -$0.55 [1] - The revenue exceeded the Zacks Consensus Estimate of $79.35 million, resulting in a surprise of +3.00% [1] Group 2 - Key metrics indicate that Travere's stock has returned +16% over the past month, while the Zacks S&P 500 composite has decreased by -0.7% [3] - The stock currently holds a Zacks Rank 4 (Sell), suggesting potential underperformance against the broader market in the near term [3] Group 3 - Revenue from Tiopronin products (Thiola) was $19.98 million, slightly below the average estimate of $20.90 million, representing a year-over-year change of -0.8% [4] - Total net product sales reached $75.86 million, exceeding the estimated $69.96 million [4] - Revenue from FILSPARI was $55.88 million, surpassing the average estimate of $49.31 million, with a year-over-year increase of +181.7% [4] - License and collaboration revenue was reported at $5.87 million, above the average estimate of $4.20 million, reflecting a year-over-year change of +322.4% [4]

Group 1 - Travere Therapeutics reported a quarterly loss of $0.47 per share, better than the Zacks Consensus Estimate of a loss of $0.55, and improved from a loss of $1.76 per share a year ago, representing an earnings surprise of 14.55% [1] - The company posted revenues of $81.73 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 3%, and showing significant growth from year-ago revenues of $41.37 million [2] - Travere shares have increased by approximately 19.5% since the beginning of the year, contrasting with the S&P 500's decline of -5.3% [3] Group 2 - The earnings outlook for Travere is uncertain, with current consensus EPS estimates at -$0.45 for the coming quarter and -$1.47 for the current fiscal year, alongside revenues of $83.04 million and $356.83 million respectively [7] - The Zacks Rank for Travere is currently 4 (Sell), indicating expectations of underperformance in the near future due to unfavorable estimate revisions [6] - The Medical - Biomedical and Genetics industry, to which Travere belongs, is currently in the top 32% of Zacks industries, suggesting a favorable environment for stocks within this sector [8]