Welcome to our dedicated page for Travere Therapeutics news (Ticker: TVTX), a resource for investors and traders seeking the latest updates and insights on Travere Therapeutics stock.
News and updates for Travere Therapeutics, Inc. (TVTX) center on its work as a biopharmaceutical company focused on rare kidney, liver and metabolic diseases. Company announcements frequently highlight progress with FILSPARI (sparsentan), an oral, non-immunosuppressive therapy approved to slow kidney function decline in adults with primary IgA nephropathy (IgAN), and under supplemental FDA review as a potential treatment for focal segmental glomerulosclerosis (FSGS).
Investors following TVTX news can track regulatory milestones such as FDA review timelines, PDUFA target action dates and review extensions for the FILSPARI sNDA in FSGS. Travere also reports new clinical data from the Phase 3 DUPLEX and Phase 2 DUET studies in FSGS, as well as from PROTECT, SPARTAN and real-world analyses in IgAN. These updates often focus on proteinuria reduction, kidney function outcomes and correlations between biomarker changes and long-term kidney failure risk.
Travere’s news flow includes financial results and preliminary revenue updates, typically furnished via press releases and Form 8‑K filings, along with commentary on commercial performance of FILSPARI in IgAN. The company also issues releases on pipeline developments, including the planned restart of the pivotal Phase 3 HARMONY Study of pegtibatinase for classical homocystinuria (HCU) and long-term metabolite reduction data from the COMPOSE study.
Additional news items cover partnership activities with CSL Vifor and Renalys Pharma, anticipated regional filings and launches, and Travere’s participation in major medical and investor conferences such as the American Society of Nephrology Kidney Week and large healthcare investment meetings. This page aggregates these developments so readers can follow how clinical, regulatory, commercial and partnership events may shape the company’s rare disease portfolio over time.
The FDA has accepted Travere Therapeutics' (NASDAQ: TVTX) supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) to treat focal segmental glomerulosclerosis (FSGS). The PDUFA target action date is set for January 13, 2026, with plans for an advisory committee meeting.
If approved, FILSPARI would become the first and only FDA-approved treatment for FSGS, a rare kidney condition leading to kidney failure. The drug is a non-immunosuppressive, oral medication targeting podocyte injury through ETAR and AT1R blockade. The sNDA is supported by the Phase 3 DUPLEX and Phase 2 DUET studies, which showed superior and sustained reductions in proteinuria compared to irbesartan, with a comparable safety profile.
Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity awards to six new employees on May 10, 2025. The Compensation Committee approved restricted stock units (RSUs) covering 35,900 shares of common stock. While granted outside of the company's 2018 Equity Incentive Plan, these RSUs follow the plan's terms and were awarded as employment inducements under Nasdaq Listing Rule 5635(c)(4). The RSUs feature a four-year vesting schedule, with 25% of shares vesting annually on the grant date anniversary, contingent on continued employment.
Travere Therapeutics (NASDAQ: TVTX) has announced its participation in three upcoming investor conferences in May and June 2025. The company will present at the BofA Securities 2025 Healthcare Conference on May 14 at 3:40 p.m. PT and the Jefferies Global Healthcare Conference on June 4 at 3:10 p.m. ET. Additionally, Travere will participate in the Scotiabank Third Annual Healthcare Canadian Investor Day on June 17. Live webcasts for the BofA and Jefferies presentations will be available on Travere's investor relations website, with replays accessible for 30 days after each event.
Travere Therapeutics and CSL Vifor have achieved a significant milestone as the European Commission converts the conditional approval of FILSPARI to standard marketing authorization for treating IgA nephropathy (IgAN).
FILSPARI, the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe, is now authorized for adult patients with primary IgAN showing urine protein excretion ≥1.0 g/day. The approval spans all EU member states, Iceland, Liechtenstein, and Norway.
The decision follows positive results from the Phase 3 PROTECT Study, which showed FILSPARI significantly slowed kidney function decline compared to irbesartan over two years. The UK's MHRA has also converted FILSPARI's conditional approval to standard approval. The drug is currently available in Germany, Austria, and Switzerland.
Following this approval, Travere expects to receive a $17.5 million milestone payment from CSL Vifor, with additional milestone payments possible based on market access and sales achievements.
CSL Vifor and Travere Therapeutics have achieved a significant milestone as the European Commission converts the conditional approval of FILSPARI to standard marketing authorization for treating IgA Nephropathy (IgAN).
FILSPARI, the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN treatment, is currently available in Germany, Austria, and Switzerland. The approval covers all EU member states, Iceland, Liechtenstein, and Norway.
The decision follows positive phase-III PROTECT study results, which showed FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. The drug is approved for adults with primary IgA nephropathy with specific urine protein excretion levels.
This standard approval, granted without changes to the indication, validates the clinical data and marks an important advancement for IgAN patients across Europe.
Travere Therapeutics (NASDAQ: TVTX) has scheduled its first quarter 2025 financial results announcement for Thursday, May 1, 2025, after U.S. financial markets close. The company will follow the earnings release with a conference call and webcast at 4:30 p.m. ET to discuss the results and provide a business update.
Investors can access the webcast and dial-in details through Travere's investor relations website at ir.travere.com/events-and-presentations. A replay of the webcast will remain available on the company's website for 30 days following the live presentation.
Travere Therapeutics (NASDAQ: TVTX) has announced the granting of inducement equity awards to six new employees by its Board's Compensation Committee on April 10, 2025. The grants consist of restricted stock units (RSUs) covering 31,100 shares of common stock.
The RSUs were granted outside of the company's 2018 Equity Incentive Plan but are subject to its terms, serving as material inducements for new employee recruitment in accordance with Nasdaq Listing Rule 5635(c)(4).
The vesting schedule extends over four years, with 25% of shares vesting annually on the grant date anniversary, contingent on continued employment with Travere.
Travere Therapeutics (TVTX) announced three presentations at the upcoming National Kidney Foundation Spring Clinical Meetings 2025 in Boston. The highlight is a late-breaking oral presentation featuring new analyses from the Phase 3 DUPLEX Study of FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS).
Key findings show that FILSPARI achieved partial and complete proteinuria remission more quickly and frequently compared to irbesartan, with patients showing low rates of kidney failure. Additional presentations include data from the Phase 2 SPARTAN Study demonstrating FILSPARI's effectiveness as first-line treatment in newly diagnosed IgA nephropathy (IgAN) patients, showing rapid proteinuria reduction and decreased sCD163 inflammatory biomarker levels.
The presentations will take place on April 10, 2025, including real-world case studies highlighting FILSPARI's effectiveness across various IgAN patient backgrounds, particularly those with high proteinuria and prior treatments.
Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking priority review for FILSPARI® (sparsentan) to treat focal segmental glomerulosclerosis (FSGS). The submission is backed by Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated FILSPARI's superior efficacy in reducing proteinuria compared to irbesartan in both adults and children.
FILSPARI, a non-immunosuppressive oral medication targeting podocyte injury, could become the first FDA-approved treatment for FSGS, a rare kidney condition and leading cause of kidney failure. The drug is currently approved for IgA nephropathy to slow kidney function decline.
The FDA has 60 days to accept the application for review, with a decision expected in Q2 2025. Additionally, the FDA has deemed REMS monitoring for embryo-fetal toxicity no longer necessary, and the company plans to submit an amendment to modify liver monitoring requirements, with a PDUFA target date of August 28, 2025.