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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 major developments in its drug pipeline and financial results for Q3 2022. The EMA has accepted the CMA application for sparsentan for IgAN, with a decision expected in H2 2023. The FDA has extended the PDUFA date to February 17, 2023. Q3 net product sales reached $50.8 million, down from $54.2 million YoY, contributing to total revenue of $53.5 million. R&D expenses increased to $59.3 million. The company reported a net loss of $69.7 million. Cash reserves stood at $506.3 million, supporting ongoing programs in rare kidney diseases.
Travere Therapeutics (NASDAQ: TVTX) announced presentations at the ASN Kidney Week 2022, detailing long-term clinical data for svarsentan in treating focal segmental glomerulosclerosis (FSGS) and insights into IgA nephropathy (IgAN). The studies include a 240-week analysis of the DUET Study, showcasing sparsentan's efficacy and safety. With Orphan Drug Designation granted, sparsentan aims for FDA accelerated approval, potentially being the first approved treatment for both FSGS and IgAN. Presentations will occur from November 3-6, 2022, in Orlando, Florida.
Travere Therapeutics (NASDAQ: TVTX) will report its third quarter 2022 financial results on October 27, 2022, after market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a general business update. Investors can access the call via dial-in numbers or through a live webcast on the company's website, with a replay available post-event. Travere focuses on developing treatments for patients with rare diseases, aiming to address urgent treatment needs through collaboration with the rare disease community.
On October 13, 2022, Travere Therapeutics (NASDAQ: TVTX) announced a likely three-month extension of the PDUFA target action date for its NDA for sparsentan, a treatment for IgA nephropathy, originally set for November 17, 2022. Following discussions with the FDA, the company was asked to revise its Risk Evaluation Mitigation Strategy (REMS) to include liver monitoring. This update is expected to be a major amendment requiring additional review time, but no new clinical data was requested. The company remains confident in sparsentan's efficacy based on robust clinical data.
On October 10, 2022, Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity grants to seven new employees. These inducement restricted stock units (RSUs) cover a total of 25,750 shares of common stock and are part of Travere's 2018 Equity Incentive Plan. The RSUs will vest over four years, with 25% vesting on each anniversary of the grant date, contingent upon the employees' continued service. This move aligns with Nasdaq Listing Rule 5635(c)(4), aimed at attracting talent essential for the company's operations.
Travere Therapeutics (NASDAQ: TVTX) announced on September 10, 2022, that its Board of Directors granted inducement restricted stock units (RSUs) covering 79,600 shares to 16 new employees. These RSUs, awarded outside the 2018 Equity Incentive Plan, are part of an effort to attract talent in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs vest over four years, with 25% vesting annually based on continued service with the company.
Travere Therapeutics (NASDAQ: TVTX) announced a presentation at the Society for the Study of Inborn Errors of Metabolism Annual Symposium in Freiburg, Germany, from August 30 to September 2, 2022. The focus will be on a genetic evaluation and cognitive function analysis from a longitudinal study related to classical homocystinuria (HCU). The study includes population-based estimates of HCU incidence and will showcase investigational enzyme replacement therapy, pegtibatinase, currently in Phase 1/2 trials. Authors will present findings during the poster walk on August 31, with details available electronically.
Travere Therapeutics (NASDAQ: TVTX) and CSL Vifor announced that the European Medicines Agency (EMA) has accepted the Conditional Marketing Authorization application for sparsentan, aimed at treating IgA nephropathy (IgAN). If approved in the second half of 2023, sparsentan would serve as the first non-immunosuppressive treatment for IgAN in Europe, addressing a significant unmet medical need. The EMA’s decision is supported by positive interim results from the pivotal Phase 3 PROTECT Study, showing a 49.8% reduction in proteinuria after 36 weeks. The treatment could potentially benefit over 100,000 IgAN patients in the U.S.
The European Medicines Agency (EMA) has accepted the Conditional Marketing Authorization (CMA) application for sparsentan, a treatment for IgA nephropathy (IgAN)
If approved, sparsentan will be a first-in-class non-immunosuppressive therapy addressing a significant unmet need in Europe. The application is supported by positive interim results from the PROTECT Study, showing a 49.8% reduction in proteinuria compared to 15.1% in controls, indicating strong efficacy.
On August 10, 2022, Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity grants to 29 new employees, comprising 101,500 restricted stock units (RSUs). These RSUs are part of the company’s efforts to attract talent and are issued outside of the 2018 Equity Incentive Plan, in compliance with Nasdaq rules. The RSUs will vest over four years, with 25% vesting annually, contingent on the employees’ continued service.
Travere focuses on developing treatments for rare diseases, emphasizing their commitment to patient care and innovative therapies.
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