Travere Therapeutics Eyes April 13 FSGS Approval and HCU Trial Restart
Travere expects an FDA decision on its supplemental NDA for sparsentan in FSGS by April 13 after responding to late-stage FDA questions, citing high confidence in approval from a pivotal trial versus irbesartan. Its Phase 3 HARMONY homocystinuria trial restarts this quarter backed by $323 million cash.
1. FSGS Supplemental NDA Timeline
Travere responded quickly to FDA information requests received in December and now awaits an April 13 decision on its sparsentan supplemental NDA for FSGS, highlighting a head-to-head study showing superior proteinuria reduction versus irbesartan and management’s high confidence in approvability.
2. HCU Phase 3 HARMONY Trial Restart
Following resolution of manufacturing scale-up challenges, Travere is restarting its Phase 3 HARMONY study of pegtibatinase in homocystinuria this quarter, preparing for rapid trial enrollment and execution.
3. Commercial and Financial Position
The company closed 2025 with its strongest commercial quarter for FILSPARI in IgA nephropathy, supported by an expanded field team, and holds $323 million in cash with exclusivity through 2033 to fund ongoing rare disease programs.