Interactions with the FDA regarding FSGS, REMS Modification Strategy, Patient Uptake and Market Growth, Competitive Dynamics and Market Positioning, FSGS Advisory Committee and Proteinuria as an Endpoint are the key contradictions discussed in
Therapeutics' latest 2025Q2 earnings call.
Strong Financial Performance:
-
reported U.S. net product sales for FILSPARI at approximately
$71.9 million in Q2 2025, demonstrating
significant year-on-year growth.
- The growth was driven by strong demand, expansion, and deepening of the prescriber base, along with efficiencies in fulfillment and solid therapy compliance.
IgA Nephropathy Market Expansion:
- FILSPARI achieved its strongest commercial quarter to date in IgA nephropathy, with
745 new patient start forms, representing
a 43% increase compared to the same period last year.
- This performance reflects the increasing recognition of FILSPARI's nephroprotective profile and its adoption as a foundational therapeutic option by nephrologists.
FSGS Potential and Regulatory Milestones:
- Travere submitted a sNDA for FILSPARI in FSGS, with a PDUFA date of January 13, 2026.
- The advancement of this sNDA process, if approved, would position FILSPARI as the first-ever treatment approved for FSGS, presenting a significant growth opportunity.
Clinical Trial Progress:
- The SPARTAN study showed FILSPARI-treated patients in IgAN achieved approximately
70% proteinuria reduction, with nearly
60% reaching complete proteinuria remission.
- The study's results support FILSPARI's potential role in modifying the underlying disease and reinforce its role as a nephroprotective treatment option.
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