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Travere Therapeutics(TVTX) - 2024 Q3 - Quarterly Results
2024-10-31 12:05
Exhibit 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Reports Third Quarter 2024 Financial Results ® FILSPARI (sparsentan) received full FDA approval as the only non-immunosuppressive treatment that significantly slows kidney function decline in IgAN Type C meeting scheduled with FDA to discuss potential sNDA submission for FILSPARI in FSGS sNDA requesting modification of liver monitoring for FILSPARI submitted to FDA Net product sal ...
Travere Therapeutics Faces Challenges But Holds Promise With Filspari Beyond IgAN
Seeking Alpha· 2024-09-30 12:00
Company Overview - Travere Therapeutics, Inc. (NASDAQ: TVTX) focuses on treatments for rare kidney and metabolic diseases [1] - The company's portfolio includes FDA-approved drugs such as Filspari (Sparsentan) for IgA Nephropathy (IgAN) and Thiola (Tiopronin) for cystinuria [1] Recent Developments - Filspari received full FDA approval in September 2024, which expanded its label and increased patient access [1]
Travere Therapeutics Announces Voluntary Pause of Enrollment in the Phase 3 HARMONY Study of Pegtibatinase Related to Commercial Manufacturing Scale-Up
GlobeNewswire News Room· 2024-09-26 20:01
SAN DIEGO, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced a voluntary pause of enrollment in the Phase 3 HARMONY Study evaluating pegtibatinase for the treatment of classical homocystinuria (HCU). The voluntary enrollment pause enables the Company to work to address necessary process improvements in manufacturing scale-up to support commercial scale manufacturing as well as full enrollment in the HARMONY Study. Patients currently enrolled in pegtibatinase studi ...
Travere (TVTX) Soars 5.9%: Is Further Upside Left in the Stock?
ZACKS· 2024-09-17 13:40
Travere Therapeutics (TVTX) shares rallied 5.9% in the last trading session to close at $14.27. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 55.3% gain over the past four weeks. The company markets Filspari (sparsentan), an oral non-immunosuppressive drug approved for treating IgA nephropathy (IgAN), a rare kidney disease. Filspari has seen strong market demand, generating $47 million in sales in the first ...
Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug
ZACKS· 2024-09-09 17:00
Core Viewpoint - Travere Therapeutics received full FDA approval for its oral nonimmunosuppressive drug Filspari (sparsentan) for the treatment of IgA nephropathy (IgAN), marking it as the only nonimmunosuppressive medication in this space [1] Company Summary - Filspari was initially granted accelerated approval in February 2023 to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression [2] - Following the full approval, Filspari's label expansion allows treatment for a broader patient population, including those at lower risk of disease progression [3] - Travere's shares increased nearly 11% after the announcement, with a year-to-date stock increase of 22.1%, contrasting with the industry's 2.8% decline [3] Clinical Study Insights - The approval was based on the pivotal phase III PROTECT study, which showed that Filspari preserved long-term kidney function compared to irbesartan [5] - The modified intention to treat (ITT) analysis included all patients, even those who stopped treatment, which was favored by the FDA [6] - The PROTECT study achieved a mean eGFR slope of -3.0 mL/min/1.73 m/year for Filspari compared to -4.2 mL/min/1.73 m/year for irbesartan [8] Regulatory and Safety Considerations - Filspari is included in the FDA's Risk Evaluation and Mitigation Strategies (REMS) program, requiring monitoring of liver enzymes before and during treatment [9] - The drug carries a boxed warning for severe birth defects if taken during pregnancy [10] Competitive Landscape - Calliditas Therapeutics dominates the IgAN space with its drug Tarpeyo, which received full FDA approval in December 2023 [11] - Novartis entered the IgAN market with the accelerated approval of Fabhalta for reducing proteinuria, marking its first FDA approval in the renal pipeline [13] - Novartis is also developing additional candidates in the IgAN indication, including atrasentan and zigakibart, following its acquisition of Chinook Therapeutics [14]
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
GlobeNewswire News Room· 2024-09-05 21:34
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years Conversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation compared to the active comparator irbesartan in the only Phase 3 headto-head trial conducted in IgAN As an or ...
Travere Therapeutics: Judgement Day Is Nigh For Sparsentan
Seeking Alpha· 2024-08-30 20:23
Chris Ryan/OJO Images via Getty Images Investment Overview - Background To Upcoming PDUFA - Failed Confirmatory Study Hammers Share Price The last time I covered Travere Therapeutics (NASDAQ:TVTX) it was September 22, 2023, and the San Diego-based biotech's stock price was in free-fall. Earlier that day, the company shared data from a Phase 3 clinical study of its lead asset Filspari (sparsentan), showing that the drug had failed to meet a key primary endpoint, unable to demonstrate a statistically signific ...
Travere Therapeutics to Present Abstracts at the Society for the Study of Inborn Errors of Metabolism Annual Symposium 2024
GlobeNewswire News Room· 2024-08-22 20:30
Core Insights - Travere Therapeutics will present two posters on classical homocystinuria (HCU) at the SSIEM annual symposium in Porto, Portugal, from September 3-6, 2024 [1][2] - The presentations will include trial designs for the pivotal Phase 3 HARMONY Study and the ENSEMBLE long-term extension study of pegtibatinase, an investigational enzyme replacement therapy for classical HCU [2][3] Company Overview - Travere Therapeutics is focused on developing therapies for rare diseases, particularly classical HCU, which is caused by a deficiency in the cystathionine beta synthase (CBS) enzyme [4][6] - The company aims to provide innovative treatment options for patients with rare diseases, emphasizing the urgency of addressing treatment needs [6] Product Information - Pegtibatinase is a PEGylated, recombinant enzyme replacement therapy designed to address the underlying cause of classical HCU [5] - The HARMONY Study is a global, randomized, multi-center, double-blind, placebo-controlled Phase 3 clinical trial aimed at evaluating the efficacy and safety of pegtibatinase [5] - Preliminary data from the Phase 1/2 COMPOSE Study indicated a 67.1% mean relative reduction in total homocysteine levels from baseline after 12 weeks of treatment with the highest dose of pegtibatinase [5] Clinical Studies - The HARMONY Study and ENSEMBLE long-term extension study will be presented as part of the SSIEM symposium, highlighting their significance in the treatment landscape for classical HCU [2][3] - The COMPOSE Study will also present findings on the safety of pegtibatinase in pediatric participants aged 5 to under 12 years with classical HCU [2][3]
Travere Therapeutics to Present at Upcoming Investor Conferences
GlobeNewswire News Room· 2024-08-06 20:30
SAN DIEGO, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that company management will present in the following upcoming investor conferences in August: 2024 Wedbush PacGrow Healthcare Conference Tuesday, August 13, 2024, at 2:30 p.m. ET Canaccord Genuity 44th Annual Growth Conference Wednesday, August 14, 2024, at 12:30 p.m. ET A live webcast of the Canaccord Genuity 44th Annual Growth Conference presentation will be accessible on the Investor page of Travere's ...
Travere Therapeutics to Present at Upcoming Investor Conferences
Newsfilter· 2024-08-06 20:30
SAN DIEGO, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that company management will present in the following upcoming investor conferences in August: 2024 Wedbush PacGrow Healthcare Conference Tuesday, August 13, 2024, at 2:30 p.m. ET Canaccord Genuity 44th Annual Growth Conference Wednesday, August 14, 2024, at 12:30 p.m. ET A live webcast of the Canaccord Genuity 44th Annual Growth Conference presentation will be accessible on the Investor page of Travere's ...