Travere Therapeutics (NASDAQ:TVTX) highlighted record demand for FILSPARI in IgA nephropathy (IgAN), provided an update on the U.S. Food and Drug Administration’s review timeline for a potential focal segmental glomerulosclerosis (FSGS) indication, and discussed the restart of global site activation for its Phase 3 pegtibatinase study in classical homocystinuria (HCU) during its fourth-quarter and full-year 2025 earnings call.
FILSPARI demand and IgAN market dynamics
Chief Executive Officer Eric Dube said 2025 was defined by reaching a “new high in the number of patients” treated with the company’s approved medicines and advancing the pipeline. In IgAN, management pointed to record demand and strong fourth-quarter revenue growth “even as additional therapies entered the market,” and said physician confidence in FILSPARI continues to build as real-world experience reinforces its long-term clinical data and use as a non-immunosuppressive therapy that can be used chronically and in combination.
Heerma attributed fourth-quarter momentum to several factors, including FILSPARI’s differentiated profile as a once-daily oral, non-immunosuppressive therapy; simplified REMS monitoring requirements; and the publication of KDIGO guidelines. He also said adoption is increasing in IgAN patients with proteinuria levels below 1.5 grams per gram, consistent with guideline direction toward earlier intervention and lower targets. When asked to quantify what proportion of fourth-quarter patient start forms came from patients below 1.5 grams per gram, Heerma said the company has not broken that out by percentage but noted the median proteinuria level in start forms “continues to go down” and is well below 1.5.
On the competitive landscape, Heerma said the company is not seeing signs of switching or physicians sequencing B-cell therapy before FILSPARI, and described the reported early patient start activity for a competitor’s IgAN therapy as “indicative of the overall IgAN market growing.” Dube added that Travere expects market growth as innovation expands both kidney-targeted and immune-targeted treatment options.
FSGS sNDA timeline shifts to April 2026 action date
Travere reiterated that the FDA accepted its supplemental new drug application (sNDA) for an FSGS indication for FILSPARI last year. Dube said the company received notification in January that the filing included a major amendment after additional information requests received before the holidays, resulting in a new PDUFA target action date of April 13, 2026. Management said its conviction in the clinical profile of FILSPARI in FSGS remains unchanged and that the expanded commercial team is in place to execute if the indication is approved.
In response to multiple analyst questions, the company declined to provide detailed specifics on the FDA’s information requests, consistent with its policy of not commenting on ongoing reviews. However, Dube said the requests were focused on clinical benefit, and he added that the company believes proteinuria “could be used as a validated surrogate endpoint for full approval,” stating there was “nothing that we’ve seen” suggesting the agency is questioning proteinuria as an endpoint.
Chief Medical Officer Jula Inrig said Travere remains confident in FILSPARI’s FSGS profile based on the “strength and consistency” of results across the Phase 2 DUET and Phase 3 DUPLEX studies, which she described as two of the largest interventional trials conducted in FSGS. She said FILSPARI consistently reduced proteinuria versus active comparator irbesartan across heterogeneous patient populations, including primary and genetic forms, as well as pediatric patients. Inrig also stated that the magnitude of proteinuria reduction translated into a clinically meaningful reduction in kidney failure events in DUPLEX and in extrapolations using external data.
On a potential FSGS label, Chief Research Officer Bill Rote said it was still “a little bit early” for label negotiations, but the company believes FILSPARI should have broad applicability across forms of FSGS and said it submitted a label consistent with that intent. Rote also noted some changes within the FDA review team while emphasizing continuity among reviewers involved in the PARASOL project related to proteinuria and continued engagement from division leadership.
Clinical updates: IgAN data context and pegtibatinase Phase 3 design
Inrig discussed physician feedback supporting dual antagonism of endothelin and angiotensin as part of foundational treatment to preserve kidney function in IgAN. She cited a recently published secondary analysis of PROTECT showing that complete proteinuria remission to less than 0.3 grams per day—where 80% of those patients were treated with FILSPARI—was associated with an annual eGFR decline of less than 1 mL/min/year, which she said reflects meaningful kidney preservation.
When asked about comparing competitor trial updates to FILSPARI’s data, Inrig said cross-trial comparisons are not appropriate given differences in trial designs and endpoints. She reiterated PROTECT outcomes, including a 3.7 mL greater absolute preservation in eGFR at two years versus a maximum-dose active comparator, described as nominally statistically significant, and said the preferred FDA analysis for total eGFR slope included in the label was statistically significant with a treatment effect of 1.2 mL/min/year versus active comparator.
Beyond FILSPARI, Travere discussed pegtibatinase for classical HCU. Inrig described HCU as a serious genetic metabolic disorder caused by CBS enzyme deficiency that leads to toxic homocysteine accumulation and can result in thrombotic events, vision and skeletal abnormalities, and developmental delays. She said COMPOSE Phase 1/2 data demonstrated clinically meaningful reductions in total homocysteine, including normalization in one patient, along with dose response and favorable tolerability. The company also said it achieved manufacturing process optimizations in 2025.
Travere said it has resumed activating clinical sites for its pivotal Phase 3 HARMONY study and long-term extension study ENSEMBLE to enable global enrollment. Inrig detailed that HARMONY is randomized and double-blind versus placebo, with a 24-week double-blind period. The primary endpoint measures change from baseline in plasma total homocysteine averaged over weeks 6 through 12, with durability assessed as a secondary endpoint to week 24. She said the study includes screening and a pretreatment diet stabilization period and that dosing of new patients is expected to be reinitiated “in the near future.”
Financial results and outlook items
Chief Financial Officer Chris Cline reported fourth-quarter U.S. net product sales of $126.6 million and full-year 2025 net product sales of $410.5 million. FILSPARI generated $103.3 million in fourth-quarter net product sales and $322 million for the full year, while Thiola and Thiola EC contributed $23.3 million in the fourth quarter and $88.5 million for the year. Travere also recognized license and collaboration revenue of $3.1 million in the quarter and $80.3 million for the year.
- R&D expense: $57.9 million in Q4 2025 (non-GAAP adjusted $54.0 million), compared with $62.1 million in Q4 2024 (non-GAAP adjusted $58.6 million).
- SG&A expense: $101.7 million in Q4 2025 (non-GAAP adjusted $76.0 million), compared with $69.5 million in Q4 2024 (non-GAAP adjusted $51.6 million). Cline attributed the increase primarily to preparations for a potential FSGS launch, expanded sales force, royalty amortization, and increased FILSPARI commercial investment.
Travere reported fourth-quarter net income of $2.7 million, or $0.03 per basic share, compared with a net loss of $60.3 million, or $0.73 per basic share, in the prior-year quarter. Non-GAAP adjusted net income was $33.3 million, or $0.37 per basic share, versus a non-GAAP adjusted net loss of $39.0 million, or $0.47 per basic share, in Q4 2024.
As of December 31, 2025, cash, cash equivalents, and marketable securities totaled $322.8 million. Cline said the balance reflects proceeds from a $40 million milestone payment received from CSL during the quarter and approximately $10 million from proceeds related to Renalys’ acquisition by Chugai. He also noted the company recognized approximately $25 million of income from discontinued operations tied to a Mirum Pharmaceuticals sales-based milestone expected to be paid in the first half of 2026.
Looking ahead, management said it expects meaningful net product sales growth from FILSPARI to continue and indicated that gross-to-net discounts are expected to increase modestly to the mid-20% range for 2026, up from around 20% in 2025. Cline added that the first quarter typically carries the highest gross-to-net impact. He also said operating expenses are expected to grow moderately versus 2025, driven by the restart and execution of HARMONY, pegtibatinase supply, FILSPARI evidence generation, and commercial investment for a potential FSGS launch. Cline stated that the company does not anticipate a near-term need for additional capital to support its current priorities.
About Travere Therapeutics (NASDAQ:TVTX)
Travere Therapeutics, Inc (NASDAQ: TVTX) is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of therapies for rare kidney and genetic disorders. The company’s mission is to address unmet needs in conditions with limited treatment options by focusing on diseases that affect small patient populations. Travere combines research, development and commercial capabilities to bring innovative medicines to market.
The company’s lead product is sparsentan, a dual endothelin angiotensin receptor antagonist that has received accelerated approval from the U.S.
