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Travere Therapeutics (TVTX) investor relations material
Travere Therapeutics Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Company overview and pipeline highlights
Focuses on rare kidney diseases, with commercial and late-stage development activities.
FILSPARI is approved in the US, Europe, and UK for IgA nephropathy and has a pending PDUFA date for FSGS in January.
Pegtibatinase is in phase III for classical homocystinuria, with plans to restart enrollment in 2025.
Leadership expects to be first to market for FSGS therapy.
Regulatory and clinical development updates
FDA review for FSGS SNDA is on track, with no major changes in review team or process.
Advisory committee meeting for FSGS was canceled, indicating a smooth review process.
Draft labeling discussions are expected about a month before the PDUFA date.
Requested a broad label for FSGS, covering all subtypes and patients eight years and older.
Post-marketing requirements are possible but none anticipated at this stage.
Clinical data and market positioning
Phase III DUPLEX trial showed consistent proteinuria reduction but missed statistical significance on eGFR.
Post-hoc analyses and external datasets support a strong correlation between deep proteinuria reduction and lower kidney failure risk.
FILSPARI is positioned as foundational therapy, with potential for combination use as new biologics emerge.
High compliance and persistence rates observed, especially in patients with lower proteinuria.
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