Travere Therapeutics (TVTX) Company Report

Travere Therapeutics anticipates a PDUFA date of January 13 for the sNDA for FILSPARI in FSGS, with the advisory committee having been canceled.
The company is requesting a broad label for FSGS, which could expand the addressable patient population from 30,000 to 40,000-50,000 patients.
Enrollment for the Phase 3 trial of pegtibatinase for classical homocystinuria (HCU) is on track to reinitiate next year, following resolution of manufacturing scale-up challenges.
The company is well capitalized to support its three key opportunities, including the ongoing launch of FILSPARI in IgA nephropathy.

2 days ago

Transcript

Travere Therapeutics Provides Updates on FILSPARI Launch, FSGS SNDA, and Pegtibatinase Program

TVTX

Product Launch

Guidance Update

New Projects/Investments

Travere Therapeutics is awaiting an FDA decision on its Supplemental New Drug Application (SNDA) for FILSPARI in treating FSGS, with a PDUFA date of January 13. The planned advisory committee was canceled as it was deemed unnecessary after further review of the file.
The company has requested a broad indication for FSGS, which could expand the addressable patient population from an estimated 30,000 (for genetic and primary FSGS) to 40,000-50,000 patients. Payers are not expected to differentiate between FSGS types for coverage.
Enrollment for the Phase 3 study of pegtibatinase for classical homocystinuria (HCU) is on track to reinitiate next year, following a pause for manufacturing scale-up. The company expects a "nice uptake" in enrollment.
Travere Therapeutics is well capitalized to support its three key opportunities, including the ongoing launch of FILSPARI in IgA nephropathy.
Recent dynamics of IgA nephropathy revenue outpacing patient start forms are attributed to a lag in reimbursement post-full approval, a trend not expected to continue moving forward.

2 days ago

Transcript

Travere Therapeutics Provides Update on FILSPARI FSGS Approval and Pipeline

TVTX

Product Launch

Guidance Update

New Projects/Investments

Travere Therapeutics (TVTX) is on track for a PDUFA date of January 13 for FILSPARI for the treatment of FSGS, following the FDA's cancellation of the advisory committee meeting. The company anticipates draft labeling approximately one month before the PDUFA date.
The company has requested a broad indication statement for FILSPARI for FSGS, covering patients 8 years and above, which could address an estimated 30,000 patients in the US. Commercial launch preparations are underway, with plans for an incremental increase to the existing 80-plus field force.
Travere's enzyme replacement therapy, pegtibatinase, is in phase three for classical homocystinuria (HCU), with reinitiation of enrollment for the trial expected in 2026.
The company reported a strong financial position, ending Q3 with approximately $255 million in cash, which increased to nearly $300 million after a milestone payment in October, indicating no near-term capital needs.

Nov 18, 2025, 3:00 PM

Transcript

Travere Therapeutics Provides Updates on FILSPARI, FSGS Approval, and Financial Position

TVTX

Product Launch

New Projects/Investments

Guidance Update

Travere Therapeutics' medicine, FILSPARI, is approved in the U.S., Europe, and U.K. for IgA nephropathy, and the company anticipates a PDUFA date of January 13th for its therapy for FSGS, expecting to be the first approved medicine for this rare kidney disease. The FDA deemed an advisory committee for FSGS unnecessary, and the review is on track.
The company is preparing for the commercial launch of the FSGS indication, leveraging its existing 80-plus field force and planning an incremental increase, aiming for broad access pricing. They are requesting a broad indication statement for FSGS for patients 8 years and above.
Enrollment for the Phase III trial of pegtibatinase for classical homocystinuria (HCU) is on track to reinitiate in 2026.
Travere Therapeutics ended Q3 with approximately $255 million in cash, which increased to nearly $300 million after a milestone payment received in October, indicating no near-term capital needs.

Nov 18, 2025, 3:00 PM

Transcript

Travere Therapeutics Provides Update on FILSPARI FSGS Approval and Commercial Strategy

TVTX

Product Launch

New Projects/Investments

Guidance Update

Travere Therapeutics' FILSPARI is on track for a PDUFA date of January 13 for the treatment of FSGS, with the FDA having deemed an advisory committee no longer necessary.
The company ended Q3 with $255 million in cash, increasing to nearly $300 million after an October milestone payment, and has no near-term capital needs.
FILSPARI's commercial performance for IgA nephropathy is strong, supported by a reduced REMS program and inclusion in KDIGO guidelines, with an existing 80+ field force to be incrementally increased for the anticipated FSGS launch.
Travere is seeking a broad indication statement for FSGS, which could expand the addressable patient population beyond the estimated 30,000 primary and genetic FSGS patients in the US.
The company is also reinitiating phase three enrollment for pegtibatinase for classical homocystinuria in 2026.

Nov 18, 2025, 3:00 PM

Transcript

Travere Therapeutics Discusses Upcoming FSGS PDUFA and Commercial Outlook

TVTX

Product Launch

Guidance Update

New Projects/Investments

Travere Therapeutics is awaiting a PDUFA date of January 13th for its FSGS treatment, with regulatory interactions described as consistent and positive.
The company presented late-breaking data at ASN Kidney Week, highlighting the significance of achieving a 0.7 grams per gram UPCR target in FSGS patients, which correlated with a lower rate of kidney failure and consistent benefit from sparsentan.
Management anticipates a faster launch for FSGS compared to the IgAN launch, attributing this to factors such as available two-year data, a request for full approval, modified REMS, and existing payer coverage.
For IgAN, the company expects continued growth, with 700 or more new patient start forms (PSFs) as the new base after full approval, which is projected to drive meaningful revenue growth.
Travere ended Q3 with $255 million in cash, which increased to over $300 million pro forma with an October milestone, indicating a strong financial position with no near-term need for capital.

Nov 13, 2025, 9:00 PM

Transcript

Travere Therapeutics Discusses Upcoming FSGS PDUFA and FILSPARI Performance

TVTX

Product Launch

Guidance Update

New Projects/Investments

Travere Therapeutics is anticipating a PDUFA date of January 13th for FSGS, with recent late-breaking data from ASN reinforcing the consistent benefit of sparsentan in DUPLEX and RADAR studies for patients achieving the 0.7 g/g UPCR target. The company expects a much faster launch for FSGS compared to IgAN, driven by greater urgency to treat, two-year data, modified REMS, and existing payer coverage policies.
For IgAN, FILSPARI exceeded Q3 expectations and is projected to see continued meaningful revenue growth from sustained demand (700+ new patients), despite anticipated gross-to-net headwinds in Q4 and Q1.
The company reported $255 million in cash at the end of Q3, or just over $300 million pro forma with a recent milestone, indicating no near-term need for capital.

Nov 13, 2025, 9:00 PM

Transcript

Travere Therapeutics Discusses Upcoming FSGS PDUFA and IgAN Performance

TVTX

Product Launch

Guidance Update

Revenue Acceleration/Inflection

Travere Therapeutics is awaiting a PDUFA date of January 13th for its FSGS treatment, with regulatory interactions described as consistent with expectations. The company has requested an indication for patients eight years and older with FSGS, targeting an addressable population of approximately 30,000 patients if limited to primary and secondary FSGS.
Management anticipates a much faster uptake for the FSGS launch compared to the IgAN launch, attributing this to greater treatment urgency, two-year data, a full approval request, modified REMS, and existing payer coverage policies. The adult target dose is double, suggesting a higher price point.
For IgAN, the company exceeded expectations in Q3 and projects continued strong demand, with 700 or more new patients per quarter forming the new base, which is expected to drive revenue growth despite anticipated gross-to-net headwinds in Q4 and Q1.
Travere Therapeutics reported $255 million in cash at the end of Q3, increasing to $300 million pro forma after an October milestone, indicating no near-term need for capital, though profitability guidance is not yet provided due to ongoing investments.

Nov 13, 2025, 9:00 PM

Transcript

Traws Pharma Reports Third Quarter 2025 Results and Provides Business Highlights

TVTX

Earnings

Management Change

New Projects/Investments

For the quarter ended September 30, 2025, Traws Pharma reported a net loss of $4.0 million, or $0.34 per basic common and diluted common share, and held $6.4 million in cash and cash equivalents.
The company is progressing Phase 2 studies for ratutrelvir (for Acute and Long COVID), with topline data expected by year-end 2025.
On September 9, 2025, Traws Pharma acquired $2.6 million in intangible assets related to a pyrrolidine antiviral compound.
Effective October 6, 2025, Iain Dukes was confirmed as CEO, Charles Parker as CFO, and John Leaman, MD, was named an Independent Board Director.

Nov 13, 2025, 12:00 PM

Press Release

Travere Therapeutics Provides Updates on FSGS PDUFA, Filspari Performance, and Pipeline

TVTX

Product Launch

New Projects/Investments

Travere Therapeutics anticipates a PDUFA date of January 13 for its FSGS SNDA, targeting an addressable patient population of approximately 30,000. The company expects rapid uptake due to the high unmet need and lack of approved therapies for FSGS.
The launch of Filspari in IgA nephropathy is performing incredibly well with strong momentum, adding over 700 new patients each quarter. Recent label updates reduced REMS liver testing frequency to quarterly, and new data shows two-thirds of first-line patients achieve complete remission.
The company plans to reinitiate enrollment in the Phase 3 study for pegtibatinase in classical homocystinuria next year, addressing an estimated 7,000-10,000 patients in the US.
Travere Therapeutics ended the quarter with $255 million in cash (or just under $300 million pro forma), indicating a strong financial position with no near-term capital needed. The company aims to diversify its pipeline through business development in rare diseases, especially rare kidney disease.

Nov 11, 2025, 2:00 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for Travere Therapeutics.

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