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.
Travere Therapeutics (NASDAQ: TVTX) reported Q3 2024 financial results, highlighting FILSPARI's full FDA approval as the only non-immunosuppressive treatment for IgAN. Net product sales reached $61.0 million, with FILSPARI contributing $35.6 million. Total revenue was $62.9 million. The company received 505 new patient start forms for FILSPARI during Q3. R&D expenses decreased to $51.7 million from $60.6 million year-over-year. The company reported a net loss of $54.8 million ($0.70 per share) and held $277.4 million in cash and equivalents as of September 30, 2024.
Travere Therapeutics presented new data for FILSPARI (sparsentan) at ASN Kidney Week 2024, showing significant clinical benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). The SPARTAN Study demonstrated nearly 60% of first-line IgAN patients achieved complete remission, with approximately 70% proteinuria reduction over 24 weeks. The SPARTACUS Study showed FILSPARI's effectiveness in combination therapy, with one-third of patients achieving 50% proteinuria reduction when added to SGLT2i. In genetic FSGS patients, typically treatment-resistant, FILSPARI delivered sustained proteinuria reduction and long-term kidney health benefits.
Travere Therapeutics (NASDAQ: TVTX) has announced its plans to report third quarter 2024 financial results on Thursday, October 31, 2024, before the U.S. financial markets open. The company will host a conference call and webcast at 8:30 a.m. ET to discuss the financial results and provide a general business update.
Investors and interested parties can access the webcast and dial-in information on the Investor page of Travere's website at ir.travere.com/events-presentations. An archived version of the call will be available for 30 days on the company's website following the live webcast.
Travere Therapeutics and CSL Vifor have announced that Swissmedic has granted temporary marketing authorization for FILSPARI® (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with specific urine protein excretion levels. The approval is based on results from the Phase 3 PROTECT Trial, which showed statistically significant and clinically meaningful outcomes.
FILSPARI offers a once-daily, oral, non-immunosuppressive treatment that targets kidney damage directly and has demonstrated superior results compared to maximally dosed irbesartan. This approval follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. Both companies express enthusiasm about providing access to this innovative treatment for the Swiss IgAN community.
CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.
Travere Therapeutics (Nasdaq: TVTX) will present 11 abstracts at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, CA, from October 23-27, 2024. The presentations will showcase new data on FILSPARI® (sparsentan), the only approved kidney-targeted medicine for IgA nephropathy (IgAN).
Key highlights include:
- Efficacy and safety results of FILSPARI as a first-line treatment in newly diagnosed IgAN patients (SPARTAN Study)
- Analysis of FILSPARI's clinical benefit in IgAN regardless of baseline proteinuria (PROTECT Study)
- Patient-reported outcomes from the PROTECT and DUPLEX Studies
- Data on FILSPARI in combination with SGLT2 inhibitors
- A late-breaking presentation on outcomes in patients with genetic focal segmental glomerulosclerosis (gFSGS) from the DUPLEX Study
The presentations will cover various aspects of FILSPARI's use in IgAN and FSGS, including its efficacy as a first-line treatment and in combination with other therapies.
Travere Therapeutics (Nasdaq: TVTX) has announced a voluntary pause in enrollment for its Phase 3 HARMONY Study of pegtibatinase, a potential treatment for classical homocystinuria (HCU). This decision was made to address necessary process improvements in manufacturing scale-up for commercial production. Currently enrolled patients will continue to receive study medication from unaffected small-scale batches.
The pause was initiated after the company determined that the desired drug substance profile was not achieved in the recent scale-up process. Travere expects to restart enrollment in the HARMONY Study no earlier than 2026. As a result, the company anticipates a reduction in research and development expenses by more than $30 million in 2025 compared to 2024. Travere's cash reserves of $325.4 million as of June 30, 2024, are expected to support operations into 2028.
Travere Therapeutics (NASDAQ: TVTX) announced that on September 10, 2024, its Compensation Committee granted inducement equity grants to six new employees. These grants consist of restricted stock units (RSUs) covering a total of 33,500 shares of common stock. The RSUs were granted outside of Travere's 2018 Equity Incentive Plan but are subject to its terms. They were provided as inducements for new employees joining Travere, in compliance with Nasdaq Listing Rule 5635(c)(4). The RSUs have a four-year vesting schedule, with 25% of the shares vesting annually on the grant date anniversary, contingent on the employee's continued service with Travere.
Travere Therapeutics (NASDAQ: TVTX) has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will present on Tuesday, September 17, 2024, at 9:45 a.m. ET. This event provides an opportunity for investors and interested parties to gain insights into Travere's latest developments and strategies.
A live webcast of the presentation will be available on the Investor page of Travere's website at ir.travere.com/events-presentations. For those unable to attend the live event, a replay will be accessible for up to 30 days following the conference. This allows stakeholders to stay informed about Travere's progress and future plans in the healthcare sector.
Ligand Pharmaceuticals (Nasdaq: LGND) announced that its partner Travere Therapeutics received full FDA approval for FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) at risk of progression. This approval is based on positive long-term results from the PROTECT Study, showing FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.
Key points:
- FILSPARI is the only non-immunosuppressive treatment for IgAN
- Ligand is entitled to a 9% royalty on worldwide net sales of FILSPARI
- FILSPARI demonstrated superior long-term kidney function preservation compared to irbesartan
- The FDA-approved label includes two-year efficacy data
Ligand's CEO, Todd Davis, expressed optimism about FILSPARI's potential as a significant revenue driver for the company in the coming years.
FAQ
What is the current stock price of Travere Therapeutics (TVTX)?
What is the market cap of Travere Therapeutics (TVTX)?
