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Travere Therapeutics Announces Late-Breaking Data from Phase 3 DUPLEX Study of FILSPARI in FSGS Presented at the American Society of Nephrology (ASN) Kidney Week 2025
Businesswire· 2025-11-06 16:00
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]
Travere Therapeutics(TVTX) - 2025 Q3 - Earnings Call Presentation
2025-10-30 20:30
Travere Therapeutics Corporate Overview October 2025 2 rare for life. We are in At Travere Therapeutics, we are a biopharmaceutical company that comes together every day to help patients, families, and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent — that is why our global team works with the rare disease community to identify, develop, and deliver life-changing therapies. Forward-Looking Statements This presentation co ...
Travere Therapeutics (TVTX) Earnings Call Presentation
2025-07-03 08:39
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]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
GlobeNewswire News Room· 2025-06-23 15:55
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]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
GlobeNewswire News Room· 2025-06-06 15:44
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]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc.  - TVTX
GlobeNewswire News Room· 2025-06-02 17:30
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]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
Prnewswire· 2025-05-20 22:06
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]
CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy
Prnewswire· 2025-04-29 06:00
Core Points - The European Commission has converted the conditional marketing approval of FILSPARI (sparsentan) into a standard marketing authorization for the treatment of IgA nephropathy (IgAN) [1][2] - This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in February 2025 [1][2] - The approval is based on comprehensive data from the phase-III PROTECT study, which demonstrated that FILSPARI significantly slowed kidney function decline compared to irbesartan [1][2][9] Company Overview - CSL Vifor is a global partner specializing in pharmaceuticals and innovative therapies for iron deficiency and nephrology, headquartered in St. Gallen, Switzerland [3] - Travere Therapeutics is a biopharmaceutical company focused on developing therapies for rare diseases, emphasizing the urgent need for treatment options [5] Product Information - FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN, currently available in Germany, Austria, and Switzerland [3][11] - It is a non-immunosuppressive therapy with high selectivity for the endothelin A receptor and the angiotensin II subtype 1 receptor [10][11] Clinical Study Insights - The PROTECT study is one of the largest interventional studies in IgAN, involving 404 patients and comparing the efficacy of FILSPARI to irbesartan [8][9] - The study met its primary endpoint, showing a mean reduction in proteinuria of 49.8% for FILSPARI compared to 15.1% for irbesartan after 36 weeks [9]