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Travere Therapeutics, Inc. (NASDAQ: TVTX) is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare kidney, liver, and metabolic diseases. The company's key focus is the development of its investigational product candidate, sparsentan. This novel therapy is in late-stage development for treating focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), both rare kidney disorders that can lead to end-stage kidney disease.
Travere Therapeutics has made significant strides in its mission, marked by several recent achievements. The company reported positive topline data from the pivotal phase-III PROTECT study of sparsentan in IgAN, showing a substantial reduction in proteinuria and potential long-term benefits in preserving kidney function. This led to the conditional marketing authorization of sparsentan under the brand name FILSPARI® in Europe and anticipated full approval in the U.S.
Additionally, Travere Therapeutics is advancing other innovative therapies. The company is exploring the potential of pegtibatinase as the first disease-modifying treatment for classical homocystinuria (HCU), with topline data expected in 2026.
Travere's strategic partnerships, such as with CSL Vifor, amplify its reach and impact. CSL Vifor has exclusive commercialization rights for sparsentan in Europe, Australia, and New Zealand. Together, these companies are dedicated to bringing promising treatments to patients worldwide.
The company's financial condition remains robust, supported by a strong pipeline and successful trials. Travere's commitment to the rare disease community is evidenced by its relentless pursuit of better treatment options and its collaborative efforts with patients, families, and caregivers.
Travere Therapeutics (TVTX) announced significant findings from the interim analysis of the Phase 3 PROTECT Study for FILSPARI™ (sparsentan), published in The Lancet. The data showed a mean reduction in proteinuria of 49.8% after 36 weeks of treatment with FILSPARI, contrasting sharply with a 15.1% reduction for irbesartan (p<0.0001). Moreover, 20.8% of patients on FILSPARI achieved complete remission, versus 7.9% for irbesartan (p=0.0005). The results indicate FILSPARI's potential for long-term benefits on kidney function and confirm its favorable safety profile, with adverse events comparable to irbesartan. Topline results for the study's confirmatory analysis are expected in Q4 2023.
Travere Therapeutics (NASDAQ: TVTX) will participate in two upcoming conferences. The first is the Guggenheim Healthcare Talks scheduled for April 4, 2023, at 3:55 p.m. ET. The second is the BofA Securities 2023 Health Care Conference on May 10, 2023, at 3:40 p.m. PT. Live webcasts of both presentations will be available on the company's Investor page, and replays will be accessible for up to 30 days post-event. Travere is dedicated to developing therapies for rare diseases, working closely with patients and the healthcare community to address urgent treatment needs.
Travere Therapeutics (NASDAQ: TVTX) announced that interim efficacy and safety data from the Phase 3 PROTECT Study of FILSPARI™ (sparsentan) for IgA nephropathy (IgAN) will be presented at the ISN World Congress of Nephrology in Bangkok (March 30-April 2, 2023) and NKF Spring Clinical Meetings in Austin (April 11-15, 2023). FILSPARI has received U.S. accelerated approval to reduce proteinuria in IgAN patients at risk of rapid progression. The company will share findings on patient populations and long-term data from the DUET Study of sparsentan in focal segmental glomerulosclerosis (FSGS). Key presentations will highlight significant clinical trial results.
On March 10, 2023, Travere Therapeutics (NASDAQ: TVTX) announced that its Board of Directors' Compensation Committee granted inducement equity grants to four new employees. The grants include restricted stock units (RSUs) totaling 17,250 shares, designed to attract new talent under Nasdaq Listing Rule 5635(c)(4). These RSUs will vest over four years, with 25% vesting annually, contingent upon the employees' continued service. Travere is focused on developing therapies for rare diseases, emphasizing the urgency of treatment options for affected patients.
SAN DIEGO, March 14, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics (NASDAQ: TVTX) announced its participation in the 2023 Society for Inherited Metabolic Disorders (SIMD) Annual Meeting and the ACMG Annual Clinical Genetics Meeting. The company will present a quantitative systems pharmacology model for pegtibatinase, an investigational treatment for classical homocystinuria (HCU), alongside real-world data on HCU prevalence. Presentations include a poster on the development of a patient identification algorithm, and incidence estimates from the gnomAD database. Pegtibatinase has received multiple FDA designations aimed at facilitating its development.
Travere Therapeutics (Nasdaq: TVTX) has successfully completed its underwritten public offering, selling 9.7 million shares of common stock at $21.00 per share, along with 1.25 million pre-funded warrants at $20.9999 per warrant. The offering generated approximately $230 million in gross proceeds, including the full exercise of underwriters’ options. The shares were sold under a shelf registration statement effective since September 3, 2021, with Jefferies, J.P. Morgan, BofA Securities, and SVB Securities serving as joint book-running managers. This offering is part of Travere's strategy to enhance its financial position for future developments.
Travere Therapeutics has announced a public offering of 8,275,000 shares at $21.00 per share and 1,250,000 pre-funded warrants at $20.9999. Expected gross proceeds are approximately $200 million, before deductions. The offering is set to close on March 3, 2023, subject to closing conditions. Underwriters have a 30-day option to purchase an additional 1,428,750 shares. The offering is part of a shelf registration statement filed with the SEC. The company aims to assist patients with rare diseases through this funding.
Travere Therapeutics (Nasdaq: TVTX) has announced plans to conduct an underwritten public offering of $175 million of its common stock. The offering will be managed by Jefferies, J.P. Morgan, BofA Securities, and SVB Securities, who also have an option to purchase an additional 15% of the offered shares. This move follows a shelf registration statement that became effective on September 3, 2021. The offering details are subject to market conditions and certain customary closing conditions. Travere has indicated no assurance regarding the offering's completion or its specific terms.
Travere Therapeutics (NASDAQ: TVTX) announced the U.S. FDA accelerated approval of FILSPARI™ (sparsentan) for reducing proteinuria in adult patients with IgA nephropathy (IgAN) at risk of rapid disease progression, marking a significant milestone for the company. In 2022, net product sales reached $52 million in Q4 and $201 million for the full year, though sales declined from 2021 levels. R&D expenses rose to $235.8 million for 2022, driven by clinical program advancements. The company anticipates critical data releases in 2023, including confirmatory endpoints for sparsentan in both IgAN and focal segmental glomerulosclerosis (FSGS).
Travere Therapeutics has received accelerated approval from the FDA for FILSPARI™ (sparsentan), the first dual endothelin and angiotensin receptor antagonist, to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression. Interim results from the Phase 3 PROTECT Study indicated a significant 49.8% reduction in proteinuria compared to 15.1% for irbesartan. The approval allows for an expanded indication, targeting approximately 30,000-50,000 patients in the U.S. Market availability is anticipated by February 27, 2023. Confirmatory trial results are expected in Q4 2023, which will further assess kidney function decline.
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