FILSPARI achieved record 993 new PSFs for IgAN in the U.S. in the first quarter; U.S. net product sales grew 88% year over year to $105 million

FDA approval in FSGS expands total addressable FILSPARI patient population in the U.S. to more than 100,000; first FSGS patients treated within one week of approval

First new patient dosed in restarted Phase 3 HARMONY Study of pegtibatinase; Topline data expected 2H 2027

SAN DIEGO--(BUSINESS WIRE)--May 04, 2026-- 

Travere Therapeutics, Inc. (Nasdaq: TVTX) today reported its first quarter 2026 financial results and provided a corporate update.

"This has been a transformative start to the year for Travere, highlighted by the landmark approval of FILSPARI in FSGS, record demand that reinforces FILSPARI's foundational position in IgAN, and the advancement of pegtibatinase with the first new patient dosed in the restarted Phase 3 HARMONY study," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "With FILSPARI now positioned to help more than 100,000 patients across IgAN and FSGS, we see a substantial and durable growth opportunity ahead, supporting a compelling long-term trajectory for the Company."

Financial Results for the Quarter Ended March 31, 2026

U.S. net product sales for the first quarter of 2026 were $124.5 million, compared to $75.9 million for the same period in 2025. The increase is attributable to growth in sales of FILSPARI.

Research and development (R&D) expenses for the first quarter of 2026 were $57.1 million, compared to $46.9 million for the same period in 2025. The increase is primarily attributable to the restart of the Phase 3 HARMONY Study of pegtibatinase in classical HCU. On a non-GAAP adjusted basis, R&D expenses were $51.5 million for the first quarter of 2026, compared to $42.2 million for the same period in 2025.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2026 were $80.3 million, compared to $60.4 million for the same period in 2025. The difference is largely attributable to investments in preparing for FILSPARI's launch in FSGS as well as commercial investments in IgAN. On a non-GAAP adjusted basis, SG&A expenses were $69.3 million for the first quarter of 2026, compared to $53.3 million for the same period in 2025.

Total other income, net for the first quarter of 2026 was $0.2 million, compared to $1.5 million for the same period in 2025.

Net loss for the first quarter of 2026 was $37.1 million, or $0.40 per basic share, compared to a net loss of $41.2 million, or $0.47 per basic share for the same period in 2025. On a non-GAAP adjusted basis, net income for the first quarter of 2026 was $4.1 million, or $0.05 per basic share, compared to a net loss of $16.9 million, or $0.19 per basic share for the same period in 2025.

As of March 31, 2026, the Company had cash, cash equivalents, and marketable securities of $264.7 million. This amount does not include the $25 million sales-based milestone from Mirum Pharmaceuticals, which was recognized in 2025 and received in April 2026.

Program Updates

FILSPARI$(R)$ (sparsentan) -- IgA Nephropathy (IgAN)

   --  993 new patient start forms (PSFs) were received during the first 
      quarter, driven by continued demand from new and repeat prescribers. 
 
   --  U.S. net product sales of FILSPARI totaled $105.2 million in the first 
      quarter of 2026, representing 88% growth versus the first quarter of 
      2025. 
 
   --  The SPARX Study evaluating FILSPARI in post-transplant patients with 
      recurrent IgAN or FSGS is on track to complete enrollment in the second 
      quarter of 2026. 
 
   --  At the National Kidney Foundation (NKF) Spring Clinical Meeting (May 
      7-10), the Company will present real-world data on combination treatment 
      with FILSPARI and SGLT2 inhibitors in IgAN. 
 
   --  In 2026, the Company's partner, Chugai Pharmaceutical, expects to 
      submit a New Drug Application for sparsentan in Japan. Travere remains 
      eligible to receive milestone payments related to the sparsentan 
      regulatory process and net sales achievements in licensed territories, as 
      well as tiered royalties. 

FILSPARI(R) (sparsentan) -- Focal Segmental Glomerulosclerosis $(FSGS)$

   --  On April 13, 2026, the U.S. Food and Drug Administration (FDA) approved 
      FILSPARI to reduce proteinuria in adult and pediatric patients aged 8 
      years and older with FSGS without nephrotic syndrome. 
 
   --  Patients with FSGS without nephrotic syndrome span across types of FSGS 
      and represent a population aligned with the KDIGO guidelines for treating 
      glomerular diseases. Nephrotic syndrome is commonly defined as the 
      presence of three concurrent criteria: proteinuria greater than 3.5 g/24h, 
      edema, and albumin less than 3.0 g/dL. 
 
   --  FILSPARI is the first and only FDA-approved medicine for FSGS, with an 
      estimated addressable population in the U.S. of more than 30,000 patients 
      without nephrotic syndrome. 
 
   --  The Company received its first FSGS patient start forms on the first 
      day following approval, with reimbursed FILSPARI treatments initiated 
      within the first week of approval. 
 
   --  At the NKF Spring Clinical Meeting (May 7--10), the Company will 
      present additional Phase 3 DUPLEX data, including results from patients 
      who switched from irbesartan to FILSPARI in the open-label extension. 

Pegtibatinase (TVT-058) -- Classical Homocystinuria (HCU)

   --  In the first quarter of 2026, the Company restarted enrollment 
      activities in the pivotal Phase 3 HARMONY Study of pegtibatinase for the 
      treatment of HCU. The study is expected to enroll approximately 70 
      patients aged 12 to 65 with plasma total homocysteine (tHcy) levels >=50 
      uM. The primary endpoint is change from baseline in plasma tHcy levels, 
      averaged across weeks 6 through 12, in patients receiving pegtibatinase 
      compared with those receiving placebo, with durability of response 
      through Week 24 as a key secondary endpoint. 
 
   --  In April 2026, the Company dosed the first new patient following the 
      study restart, with topline data anticipated in 2H 2027. 
 
   --  Pegtibatinase has the potential to become the first and only 
      disease-modifying therapy for people living with HCU. 

Conference Call Information

Travere Therapeutics will host a conference call and webcast today, May 4, 2026, at 4:30 p.m. ET to discuss company updates and first quarter 2026 financial results. To participate in the conference call, dial +1 (833) 461-5787 (U.S.) or +1 (585) 542-9983 (International), meeting ID 293685046 shortly before 4:30 p.m. ET. The webcast can be accessed on the Investor page of Travere's website at ir.travere.com/events-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company's website.

Use of Non-GAAP Financial Measures

To supplement Travere's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP adjusted financial measures in this press release and the accompanying tables. The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Travere's management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. In addition, Travere believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period and allows for greater transparency with respect to key financial metrics the Company uses in making operating decisions.

Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future the Company may exclude other items, or cease to exclude items that it has historically excluded, for purposes of its non-GAAP financial measures; because of the non-standardized definitions, the non-GAAP financial measures as used by the Company in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the Company's competitors and other companies.

As used in this press release, (i) the historical non-GAAP net income (loss) measures exclude from GAAP net income (loss), as applicable, stock-based compensation expense, amortization and depreciation expense, and income tax; (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, stock-based compensation expense, and amortization and depreciation expense; (iii) the historical non-GAAP R&D expense measures exclude from GAAP R&D expenses, as applicable, stock-based compensation expense, and amortization and depreciation expense; (iv) royalty expense excludes amortization expense.

About Travere Therapeutics

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