Overview
- The FDA told Travere an external advisory committee is no longer required to review its supplemental application for Filspari in focal segmental glomerulosclerosis.
- Travere said it is preparing for a potential commercial launch, with CEO Eric Dube calling the sNDA’s progress encouraging.
- If approved, Filspari would be the first treatment for FSGS, supported by Phase 3 DUPLEX and Phase 2 DUET data showing rapid, sustained proteinuria reductions versus irbesartan.
- Investors drove the stock up roughly 25% to 26% to fresh highs, with an intraday peak reported at $28.69 and a close around $27.31.
- Filspari is an oral, non‑immunosuppressive therapy targeting podocyte injury and has shown a consistent safety profile across trials.