Travere: FILSPARI FSGS sNDA PDUFA set for January 13, 2026

The document states the PDUFA target action date for the supplemental NDA seeking full approval of FILSPARI in FSGS is January 13, 2026. The company has responded to recent FDA information requests and the responses are under review. If approved, FILSPARI would be the first medication approved for FSGS.

Key facts

Filed: Jan 12, 2026, 10:04 PM
Event: PDUFA date set
Direction: Neutral
Company: TVTXTravere
Asset: sparsentan
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Apr 13, 2026 · Approved

Source excerpt

EX-99.1 2 aex991_2025q4xearningsprex.htm EX-99.1 Document EXHIBIT 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Provides Corporate Update and 2026 Outlook U.S. FILSPARI reaches all-time highs of 908 new PSFs and net product sales of approximately $103 million in 4Q 2025 Company positioned for successful commercial launch of FILSPARI in FSGS, if approved Pivotal Phase 3 HARMONY Study of pegtibatinase in classical HCU to restart in 1Q 2026 SAN DIEGO, January 12, 2026 – Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects total U.S. net product sales for the fourth quarter of 2025 to be approximately $127 million. For the fiscal year 2025, the Company expects total U.S. net product sales to be approximately $410 million. The Company ended 2025 with approximately $323 million in cash, cash equivalents, and marketable securities. The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated 2026 milestones. “The fourth quarter closed out an exceptional year of commercial execution with FILSPARI, as our teams were able to reach a record number of patients with IgAN, reinforcing its role as foundational therapy,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “As we move into 2026, we are focused on sustaining this momen

SEC 8-K