Pegtibatinase
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Travere Therapeutics(TVTX) - 2025 Q4 - Earnings Call Presentation
2026-02-19 21:30
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 ...
Travere Therapeutics (NasdaqGM:TVTX) Earnings Call Presentation
2026-01-12 21:00
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 ...
Travere Therapeutics(TVTX) - 2025 Q3 - Earnings Call Presentation
2025-10-30 20:30
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]
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]