Travere Therapeutics announced that the U.S. Food and Drug Administration has extended the review timeline for its supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026, following the submission of additional responses requested by the FDA to further characterize the clinical benefit of FILSPARI in FSGS patients.
FILSPARI is already approved by the FDA and EMA for slowing kidney function decline in adults with IgA nephropathy (IgAN). In the fourth quarter of 2025, U.S. net product sales for FILSPARI were approximately $103 million, representing a 108% year‑over‑year increase and accounting for roughly 80% of the company’s $127 million in total U.S. net product sales. For the full year 2025, total U.S. net product sales were expected to reach about $410 million, with FILSPARI contributing $322 million. These figures underscore the drug’s strong commercial traction in its current indication and provide a solid cash‑generating base for future growth.
Travere’s financial position remains robust. The company closed 2025 with about $323 million in cash, cash equivalents, and marketable securities, giving it a comfortable liquidity cushion. However, operating and net margins were negative—20.59% and 20.32% respectively—reflecting the high cost of research and development and the early‑stage nature of its pipeline. The debt‑to‑equity ratio of 4.48 indicates a leveraged balance sheet, but the company’s cash flow from operations has been improving as sales of FILSPARI in IgAN grow.
In a statement, President and CEO Eric Dube emphasized that the company remains committed to advancing FILSPARI for FSGS. He noted that the FDA’s request for additional information is a routine part of the review process and that Travere is actively working to address the agency’s concerns. Dube added that commercial preparations for a potential launch are continuing in parallel, highlighting the company’s confidence in the drug’s therapeutic value and the unmet need in the FSGS market.
Investors reacted with caution to the extension, reflecting uncertainty about the likelihood of approval and the timing of a potential launch. Analysts noted that the market was pricing in a roughly 33% chance of approval at the pre‑announcement valuation, and that a scenario requiring additional efficacy studies could further erode confidence. The extension also signals that the FDA is treating the submission as a major amendment, which may increase the risk of a complete response letter or the need for additional studies.
The FSGS indication represents a significant growth opportunity for Travere. FSGS is a rare kidney disorder with no FDA‑approved pharmacologic therapies, making FILSPARI the first and only potential treatment in this space. Approval would open a sizable market and could substantially increase the company’s revenue base. Conversely, the extension introduces regulatory uncertainty that could delay commercialization and impact the company’s long‑term financial outlook. Travere’s continued focus on addressing the FDA’s concerns and maintaining commercial momentum in IgAN positions it to capitalize on the opportunity if approval is ultimately granted.
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