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.
Travere Therapeutics Inc (TVTX) is a biopharmaceutical innovator developing therapies for rare kidney, liver, and metabolic diseases. This page provides a comprehensive repository of official company announcements, clinical trial updates, and regulatory developments.
Investors and researchers will find curated press releases detailing milestones for pipeline candidates like FILSPARI and sparsentan, along with financial disclosures and partnership announcements. Content is organized to highlight material events including FDA communications, trial phase completions, and strategic collaborations.
All updates are sourced directly from Travere Therapeutics to ensure accuracy. Bookmark this page for efficient tracking of the company’s progress in advancing treatments for IgA nephropathy, FSGS, and other rare conditions.
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.
Travere Therapeutics (TVTX) reported Q2 2022 financial results, posting total revenues of $54.2 million, comprising $51.0 million in net product sales and $3.2 million in licensing revenues. The company experienced a net loss of $67.0 million, compared to $39.0 million in Q2 2021. The FDA has accepted the NDA for accelerated approval of sparsentan for IgA nephropathy, with a PDUFA date set for November 17, 2022. Cash and equivalents stood at $553.2 million as of June 30, 2022, highlighting the company’s financial position as it aims for a potential launch of sparsentan.
Travere Therapeutics (NASDAQ: TVTX) has provided regulatory updates for its drug sparsentan aimed at treating IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). The PDUFA target action date for sparsentan's NDA submission for IgAN remains on track for November 17, 2022. After FDA feedback, the company will pursue traditional approval for sparsentan in FSGS following the ongoing Phase 3 DUPLEX Study. Additionally, pegtibatinase received Breakthrough Therapy Designation for classical homocystinuria (HCU). A corporate conference call is scheduled for August 4, 2022.
Travere Therapeutics (NASDAQ: TVTX) is set to release its Q2 2022 financial results on August 4, 2022, before the U.S. market opens. A conference call will be held at 8:00 a.m. ET to discuss the results and offer a business update. For those unable to attend live, a replay will be available from 11:00 a.m. ET on August 4 until 11:00 a.m. ET on August 11, 2022. Travere Therapeutics focuses on developing therapies for rare diseases, aligning its operations with the urgent needs of patients and their families.
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