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]

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]

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]