Company Overview - Travere Therapeutics (TVTX) experienced a significant decline in share price following the announcement of a delay in the FDA approval for its drug Filspari, intended for treating focal segmental glomerulosclerosis (FSGS) [3] - The FDA is now expected to make a decision on Filspari by April 13, which is a postponement from the original date of January [3] Market Reaction - The market reacted negatively to the news, leading to a crash in Travere Therapeutics' shares as investors processed the implications of the delay [3] - Despite the setback, Travere Therapeutics has been highlighted as a stock that has doubled in value in 2025, indicating previous strong performance prior to the announcement [6] Future Outlook - The company is under scrutiny as it approaches the new FDA decision date, with potential implications for its market position and investor sentiment [3][6] - Travere Therapeutics has received a composite rating upgrade, suggesting some analysts still see potential in the stock despite the recent challenges [8]

Core Viewpoint - Block & Leviton is investigating Travere Therapeutics, Inc. for potential securities law violations following a significant drop in share price after the FDA extended the review timeline for a key drug application [1][2]. Group 1: Company Overview - Travere Therapeutics, Inc. experienced a trading halt after its shares fell over 30% on January 13, 2026, due to the FDA's extension of the review timeline for the supplemental New Drug Application for FILSPARI [2]. - The FDA set a new PDUFA target action date of April 13, 2026, citing that additional responses from Travere constituted a major amendment and required further data to assess clinical benefit [2]. Group 2: Investigation Details - Block & Leviton is examining whether Travere Therapeutics adequately disclosed the risks associated with the review extension and if prior communications regarding the regulatory timeline were misleading [2][4]. - The firm is considering filing an action to recover losses for investors who have been affected by the decline in share value [4]. Group 3: Investor Eligibility - Any individual who purchased common stock of Travere Therapeutics and has experienced a decline in share value may be eligible to participate in the investigation, regardless of whether they have sold their investment [3]. Group 4: Whistleblower Information - Individuals with non-public information about Travere Therapeutics are encouraged to assist in the investigation or report to the SEC under the whistleblower program, potentially receiving rewards of up to 30% of any successful recovery [6]. Group 5: Firm's Reputation - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [7].

Core Viewpoint - The U.S. FDA has extended the review timeline for Travere Therapeutics' supplemental New Drug Application for FILSPARI® in the treatment of focal segmental glomerulosclerosis, with a new target action date set for April 13, 2026 [1] Group 1 - The FDA's extension follows the recent submission of additional responses requested to further characterize the clinical benefit of FILSPARI® [1]

Market Performance - U.S. stocks showed mixed performance with the Dow Jones index falling over 200 points, down 0.60% to 49,293.33, while the NASDAQ gained 0.17% to 23,773.29 and the S&P 500 dropped 0.08% to 6,971.95 [1] - In the energy sector, shares increased by 1.4%, while financial stocks decreased by 1.8% [1] Inflation Data - Inflation remained steady in December, with the Consumer Price Index rising 2.7% year over year, matching economist expectations and unchanged from November [2] - Monthly consumer prices increased by 0.3%, also in line with forecasts [2] Commodity Prices - Oil prices rose by 2.6% to $61.06, while gold increased by 0.1% to $4,620.80 [4] - Silver prices surged by 4.4% to $88.860, whereas copper fell by 0.1% to $6.0295 [4] European Market Trends - European shares were mixed, with the eurozone's STOXX 600 falling 0.08% and Spain's IBEX 35 Index rising 0.08% [5] - London's FTSE 100 slipped 0.03%, Germany's DAX gained 0.06%, and France's CAC 40 fell 0.14% [5] Asian Market Performance - Asian markets closed mixed, with Japan's Nikkei surging 3.10% and Hong Kong's Hang Seng Index gaining 0.90% [8] - Conversely, China's Shanghai Composite fell 0.64% and India's BSE Sensex decreased by 0.30% [8] Company-Specific Movements - Beyond Air Inc shares surged 172% to $2.39 following an acquisition agreement, potentially receiving up to $32.5 million [7] - Ambitions Enterprise Management Co LLC shares increased by 106% to $10.90 due to a year-over-year EPS increase [7] - TryHard Holdings Ltd shares rose by 77% to $40.96 after announcing a collaboration agreement and a $10 million share repurchase program [7] - Signing Day Sports Inc shares dropped 57% to $0.25 after announcing a public offering [7] - Travere Therapeutics Inc shares fell 32% to $23.16 following preliminary fourth-quarter financial results [7] - Wealthfront Corp shares decreased by 18% to $10.34 due to weak quarterly sales [7]

Core Viewpoint - Travere Therapeutics Inc's stock is experiencing a significant decline due to new FDA questions regarding its Filspari application, overshadowing strong fourth-quarter sales performance [1] Group 1: Stock Performance - The stock is down 32.8%, trading at $22.92, marking its largest single-day percentage loss since September 2023 [1][2] - Today's decline has brought the stock to its lowest levels since September 2025, moving away from its record high of $42.03 reached on December 24 [2] - Year-over-year, the stock still maintains a 25.9% increase [2] Group 2: Options Activity - Options trading has surged, with 6,295 calls and 23,000 puts exchanged, which is 21 times the average daily options volume [3] - The most popular option is the January 16, 2026, 17.50-strike put, with new positions being opened [3] - The stock has been placed on the short sell restricted (SSR) list today [3] Group 3: Market Sentiment - The put/call volume ratio for Travere Therapeutics is 1.49, indicating a higher than usual interest in puts, ranking above 93% of readings from the past year [4]

Group 1 - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] - Travere Therapeutics Inc expects total U.S. net product sales of $127 million for Q4 and $410 million for 2025 [1] - Travere Therapeutics will restart its Phase 3 HARMONY study in Q1 2026 [1] Group 2 - Travere Therapeutics shares fell 28.2% to $24.50 in pre-market trading [2] - Lulu's Fashion Lounge Holdings Inc shares decreased 10.4% to $10.89 after a significant rise of 79% on Monday [3] - Other stocks such as Graf Global Corp, Ready Capital Corp, and Baidu Inc also experienced declines in pre-market trading [3]

Core Viewpoint - Travere Therapeutics emphasizes its commitment to rare diseases, driven by personal connections among its team members, including the CEO, who is a rare cancer survivor [3]. Group 1: Company Overview - Travere Therapeutics is represented by CEO Eric Dube at the 44th Annual JPMorgan Healthcare Conference, highlighting the company's focus on rare diseases [1][2]. - The company adopts a patient-inspired approach in its operations, reflecting the personal experiences of its employees with rare diseases [3]. Group 2: Performance and Priorities - Travere announced updates regarding its performance expectations for 2025 and outlined three key priorities for the company [4].

Summary of Travere Therapeutics FY Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **CEO**: Eric Dube Key Points Industry and Company Focus - Travere Therapeutics is focused on rare diseases, particularly in the areas of IgA nephropathy, FSGS (Focal Segmental Glomerulosclerosis), and homocystinuria (HCU) [2][3][32] Financial Performance - Achieved **$410 million** in net revenue for 2025, with **143% growth** compared to 2024 [3][4] - Revenue breakdown: **$323 million** from Filspari and **$88 million** from the Thiola portfolio [4] - **$103 million** revenue in Q4 2025, representing **108% growth** year-over-year [13] Product Updates - **Filspari**: - Reached an all-time high of **908 new patient start forms** in Q4 2025 for IgA nephropathy [3][12] - Positioned as a foundational therapy for IgA nephropathy, with a unique once-a-day pill formulation [10][11] - Clinical data shows a **50% reduction** in proteinuria compared to the standard of care [25] - Anticipated FDA approval for FSGS, with ongoing regulatory engagement [5][6][30] - **HARMONY Study**: - Phase III program for HCU reinitiated, focusing on enzyme replacement therapy [4][32] - Current treatment options are limited, with a significant unmet need for disease-modifying therapies [33] Regulatory Engagement - Ongoing discussions with the FDA regarding the FSGS supplemental new drug application (SNDA) [5][6] - Received additional information requests from the FDA focused on clinical benefits of Filspari, not related to safety or manufacturing [5][41] Market Opportunity - Approximately **70,000 patients** diagnosed with IgA nephropathy in the U.S., with a significant number still untreated [10] - Filspari is expected to capture a larger market share as awareness and clinical use grow [30][17] - The company has not yet reached **10%** of the addressable population for IgA nephropathy, indicating substantial growth potential [16][17] Clinical Insights - The KDIGO guidelines have been updated to reflect the urgency of treating IgA nephropathy, emphasizing the need for earlier intervention [9][15] - The PARASOL Group's findings indicate that reducing proteinuria is critical for lowering the risk of kidney failure in FSGS patients [21][23] Future Outlook - Travere is committed to redefining the standard of care in IgA nephropathy, FSGS, and HCU, with a strong financial foundation to support ongoing initiatives [37][52] - The company is prepared for rapid uptake of Filspari in FSGS upon approval, leveraging existing relationships with nephrologists [30][31] Patient-Centric Approach - The company emphasizes a patient-inspired approach, with personal connections to rare diseases among its team members [2] - Highlighted the story of a patient, Jennifer, to illustrate the impact of FSGS and the need for innovative therapies [38][39] Additional Important Information - The company has a strong commitment to the rare disease community and aims to provide hope and better treatment options for patients [39][52] - The upcoming PDUFA date for FSGS is critical, with expectations for timely communication regarding FDA decisions [40][41]

Financial Performance - U.S. net product sales for FILSPARI in Q4 2025 reached approximately $103 million, representing 108% year-over-year growth[5] - Total U.S. net product sales for the fiscal year 2025 are expected to be approximately $410 million[1] - The company ended 2025 with approximately $323 million in cash, cash equivalents, and marketable securities[1] - A $40 million milestone payment was received from CSL Vifor in October 2025 following market access achievements[5] Product Development and Approvals - The PDUFA target action date for FILSPARI's sNDA seeking full approval in FSGS is January 13, 2026[5] - The pivotal Phase 3 HARMONY Study of pegtibatinase is set to restart in Q1 2026 after optimization of the manufacturing process[6] - Chugai Pharmaceutical is expected to submit a New Drug Application for sparsentan in Japan in 2026[5] - If approved, FILSPARI would be the first and only medication approved for FSGS, a rare kidney disorder[5] - The company is preparing for a New Drug Application for sparsentan for the treatment of IgAN in Japan, indicating market expansion efforts[21] Market Launch and Acceptance - The company is making continued progress with the FILSPARI launch in IgAN, with preliminary estimates of metrics related to this launch[21] - The company anticipates potential approval and commercial launch of FILSPARI in FSGS, although there are risks regarding the timing and outcome of the sNDA[21] - The ongoing commercial launch of FILSPARI in IgAN is facing risks related to market acceptance, including efficacy, safety, and pricing[21] Clinical Evidence and Research - The company anticipates continued generation of clinical evidence to support FILSPARI's role as foundational therapy in IgAN throughout 2026[5] - The company is focused on the Phase 3 HARMONY Study, with expectations to restart study activities, although timelines may be subject to change[21] Risks and Challenges - There are uncertainties regarding the company's ability to raise additional funding required for product development due to macroeconomic conditions[21] - Risks associated with the manufacturing scale-up and successful execution of commercial strategies for FILSPARI are present[21] - The company faces potential disruptions to clinical trials and commercialization activities due to global and macroeconomic conditions[21] - The company is dependent on contractors for clinical drug supply and commercial manufacturing, which introduces additional risks[21] - The company is monitoring serum potassium levels in patients treated with FILSPARI, especially when used with other agents that increase serum potassium[22]

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]