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Travere Therapeutics
Travere Therapeutics (TVTX) investor relations material
Travere Therapeutics Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary11 Feb, 2026
Strategic focus and recent progress
Focused on rare diseases: IgA nephropathy, FSGS, and homocystinuria, with significant progress in all three programs last year.
FILSPARI is in its third year of launch for IgA nephropathy, showing strong commercial performance and aiming to become foundational care.
sNDA for FILSPARI in FSGS is under FDA review, with a PDUFA date set for April 13 after an extension due to additional FDA information requests.
Manufacturing scale-up challenges for HCU have been resolved, and the phase III HARMONY study is set to restart this quarter.
Regulatory and clinical updates
High confidence in FILSPARI's approvability for FSGS, supported by strong pivotal study data showing superiority over irbesartan.
FDA's late information requests were straightforward, and all have been addressed; awaiting draft labeling and potential approval.
Noted FDA staff turnover and new reviewers, but strong engagement continues, with long-term involvement from the Cardiorenal Director.
Will enter a quiet period in early March ahead of the PDUFA date.
Commercial strategy and market dynamics
Anticipates rapid uptake of FILSPARI in FSGS due to urgent unmet need, strong execution, and nephrologist familiarity from IgA nephropathy.
Expanded field team and high overlap (90%) between IgAN and FSGS prescribers; preparing to reach pediatric nephrologists for FSGS.
Expects faster FSGS uptake compared to IgAN, driven by full approval, quarterly REMS, payer access, and urgency among patients and physicians.
Competitive landscape in FSGS is evolving, but no direct competitors with the same mechanism are expected for several years.
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Next Travere Therapeutics earnings date
Q4 202519 Feb, 2026
Travere Therapeutics
Next Travere Therapeutics earnings date
Q4 202519 Feb, 2026
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Frequently asked questions
Travere Therapeutics Inc is a biopharmaceutical company focused on developing and commercializing therapies for rare diseases. The company’s research and commercial efforts target conditions related to nephrology, hepatology, and metabolic disorders. It serves patients through both approved treatments and investigational programs. The company is headquartered in San Diego, California, and its shares are listed on the NASDAQ.
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