Earnings summaries and quarterly performance for Travere Therapeutics.
Executive leadership at Travere Therapeutics.
Board of directors at Travere Therapeutics.
Research analysts who have asked questions during Travere Therapeutics earnings calls.
Laura Chico
Wedbush Securities
4 questions for TVTX
Anupam Rama
JPMorgan Chase & Co.
3 questions for TVTX
Jason Zemansky
Bank of America
3 questions for TVTX
Prakhar Agrawal
Cantor Fitzgerald
3 questions for TVTX
Will Soghikian
Leerink Partners
3 questions for TVTX
Arseniy Shabashvili
Guggenheim Securities
2 questions for TVTX
Gregory Harrison
Scotiabank
2 questions for TVTX
Liisa Bayko
Evercore ISI
2 questions for TVTX
Mohit Bansal
Wells Fargo & Company
2 questions for TVTX
Sadia Rahman
Wells Fargo
2 questions for TVTX
Tyler Van Buren
TD Cowen
2 questions for TVTX
Vamil Divan
Guggenheim Securities
2 questions for TVTX
Yigal Nochomovitz
Citigroup Inc.
2 questions for TVTX
Alexander Thompson
Stifel
1 question for TVTX
Alex Thompson
Stifel Financial Corp.
1 question for TVTX
Charles Ndiaye
Stifel Financial Corp.
1 question for TVTX
Dina Ramadane
Bank of America
1 question for TVTX
Ed Arce
WestPark Capital
1 question for TVTX
Farzin
Jefferies
1 question for TVTX
Farzin Haque
Jefferies
1 question for TVTX
Frances Dovell
TD Cowen
1 question for TVTX
Greg Wiessner
TD Cowen
1 question for TVTX
Joe Thomas
Scotiabank
1 question for TVTX
Joseph Schwartz
Oppenheimer
1 question for TVTX
Joseph Thomas
HSBC
1 question for TVTX
Maurice Raycroft
Jefferies Financial Group
1 question for TVTX
Maury Raycroft
Jefferies
1 question for TVTX
Reena
Citigroup Inc.
1 question for TVTX
Recent press releases and 8-K filings for TVTX.
- The FDA has extended the review timeline for Travere Therapeutics' supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS), with a new Prescription Drug User Fee Act (PDUFA) target action date of April 13, 2026.
- This extension follows the submission of responses requested by the FDA, which were determined to constitute a Major Amendment to the sNDA.
- Travere Therapeutics is continuing commercial launch preparations for FILSPARI in FSGS, anticipating potential approval for what would be the first medication indicated for this rare and serious kidney disorder.
- Travere Therapeutics reported $410 million in net revenue for 2025, representing 143% growth compared to 2024, with Filspari contributing $323 million and the Thiola portfolio $88 million; the company ended 2025 with $323 million in cash.
- Filspari for IgA nephropathy achieved an all-time high of 908 new patient start forms in Q4 2025 and generated $103 million in revenue for the quarter, an 108% increase year-over-year.
- The FDA is continuing its review of the Supplemental New Drug Application (SNDA) for Filspari in FSGS, with the PDUFA date scheduled for January 14, 2026; Travere submitted responses to additional information requests from the FDA on January 10, 2026.
- The pegtibatinase phase III HARMONY study for homocystinuria (HCU) is set to reinitiate in Q1 2026.
- Travere Therapeutics achieved $410 million in net revenue for 2025, representing 143% growth compared to 2024, and ended the year with $323 million in cash.
- FILSPARI for IgA nephropathy reached an all-time high of 908 new patient start forms in Q4, contributing to $103 million in Q4 revenue, a 108% growth year-over-year.
- The FDA is continuing to review Travere's sNDA for FILSPARI in FSGS, with a PDUFA date of January 14, 2026, following the submission of responses to information requests regarding clinical benefits as of January 9, 2026.
- The pegtibatinase Phase III HARMONY study for homocystinuria (HCU) will be reinitiating this quarter (Q1 2026).
- The company states it has sufficient funding to support all three of its priorities and does not need additional capital.
- Travere Therapeutics reported preliminary Q4 2025 U.S. net product sales of approximately $127 million and full-year 2025 U.S. net product sales of approximately $410 million, ending the year with approximately $323 million in cash, cash equivalents, and marketable securities.
- FILSPARI U.S. net product sales for IgAN reached approximately $103 million in Q4 2025, representing 108% year-over-year growth, and $322 million for the full year 2025.
- The PDUFA target action date for FILSPARI in FSGS is January 13, 2026, with the company positioned for a commercial launch if approved.
- The pivotal Phase 3 HARMONY Study of pegtibatinase in classical HCU is scheduled to restart in Q1 2026.
- Travere Therapeutics reported preliminary and unaudited total U.S. net product sales of approximately $127 million for Q4 2025 and approximately $410 million for fiscal year 2025, ending the year with approximately $323 million in cash, cash equivalents, and marketable securities.
- FILSPARI U.S. net product sales reached approximately $103 million in Q4 2025, marking 108% year-over-year growth, driven by 908 new patient start forms.
- The company anticipates a PDUFA target action date of January 13, 2026, for FILSPARI in FSGS and plans to restart the pivotal Phase 3 HARMONY Study for pegtibatinase in classical HCU in 1Q 2026.
- Travere Therapeutics reported ~$410M in total net product sales for 2025 and ended the year with ~$323M in cash.
- FILSPARI (sparsentan) U.S. net product sales reached ~$103M in 4Q25, representing ~108% growth vs 4Q24. New patient start forms (PSFs) for FILSPARI in IgAN were 908 in 4Q25, a 24% increase vs 3Q25.
- The FDA accepted the sNDA for traditional approval of FILSPARI (sparsentan) for the treatment of FSGS in May 2025, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, FILSPARI could be the first medicine for FSGS, addressing up to 30,000 eligible patients in the U.S. and having a $1B+ potential.
- Enrollment in the HARMONY Study for pegtibatinase (TVT-058) in HCU, which was voluntarily paused in September 2024 due to manufacturing scale-up, is on track to restart in 1Q 2026.
- 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.
- 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.
- 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.
- 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.
Quarterly earnings call transcripts for Travere Therapeutics.
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