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]

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 ...

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 ...

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]

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 ...

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 ...

For the quarter ended June 2024, Travere Therapeutics (TVTX) reported revenue of $54.12 million, down 9.4% over the same period last year. EPS came in at -$0.90, compared to -$1.13 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $49.5 million, representing a surprise of +9.33%. The company delivered an EPS surprise of -3.45%, with the consensus EPS estimate being -$0.87. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings ...

Travere Therapeutics (TVTX) came out with a quarterly loss of $0.90 per share versus the Zacks Consensus Estimate of a loss of $0.87. This compares to loss of $1.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -3.45%. A quarter ago, it was expected that this drug developer would post a loss of $0.98 per share when it actually produced a loss of $1.76, delivering a surprise of -79.59%. Over the last four quarters, the compa ...

Received 521 new patient start forms (PSFs) for FILSPARI® (sparsentan) in the quarter representing the sixth consecutive quarter of PSF growth; Total of 2,484 PSFs received since launch Net product sales of FILSPARI totaled $27.1 million for the second quarter of 2024 representing 37% growth over the previous quarter Company well-positioned for September 5, 2024 PDUFA target action date for conversion of the U.S. accelerated approval of FILSPARI to full approval in IgAN Total revenue for the second quarter ...

SAN DIEGO, July 25, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced it will report second quarter 2024 financial results on Thursday, August 1, 2024, after the close of the U.S. financial markets. The Company will host a conference call and webcast to discuss the financial results and provide a general business update at 4:30 p.m. ET. The webcast and dial-in information can be accessed on the Investor page of Travere's website at ir.travere.com/events-presentations. Follo ...