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.
News and updates for Travere Therapeutics, Inc. (TVTX) center on its work as a biopharmaceutical company focused on rare kidney, liver and metabolic diseases. Company announcements frequently highlight progress with FILSPARI (sparsentan), an oral, non-immunosuppressive therapy approved to slow kidney function decline in adults with primary IgA nephropathy (IgAN), and under supplemental FDA review as a potential treatment for focal segmental glomerulosclerosis (FSGS).
Investors following TVTX news can track regulatory milestones such as FDA review timelines, PDUFA target action dates and review extensions for the FILSPARI sNDA in FSGS. Travere also reports new clinical data from the Phase 3 DUPLEX and Phase 2 DUET studies in FSGS, as well as from PROTECT, SPARTAN and real-world analyses in IgAN. These updates often focus on proteinuria reduction, kidney function outcomes and correlations between biomarker changes and long-term kidney failure risk.
Travere’s news flow includes financial results and preliminary revenue updates, typically furnished via press releases and Form 8‑K filings, along with commentary on commercial performance of FILSPARI in IgAN. The company also issues releases on pipeline developments, including the planned restart of the pivotal Phase 3 HARMONY Study of pegtibatinase for classical homocystinuria (HCU) and long-term metabolite reduction data from the COMPOSE study.
Additional news items cover partnership activities with CSL Vifor and Renalys Pharma, anticipated regional filings and launches, and Travere’s participation in major medical and investor conferences such as the American Society of Nephrology Kidney Week and large healthcare investment meetings. This page aggregates these developments so readers can follow how clinical, regulatory, commercial and partnership events may shape the company’s rare disease portfolio over time.
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.
Travere Therapeutics (NASDAQ: TVTX) announced on July 10, 2022, that its Compensation Committee granted inducement restricted stock units (RSUs) to 43 new employees, totaling 120,700 shares. These RSUs, which vest over four years, were awarded outside of the 2018 Equity Incentive Plan as an inducement for new hires in compliance with Nasdaq Listing Rule 5635(c)(4). This initiative underscores Travere's commitment to attracting talent as it focuses on developing therapies for rare diseases.
Meissa Vaccines has appointed Frank Glavin as its new Chief Executive Officer, bringing over 20 years of biotech experience, including successful transitions from lab to clinic. Martin Moore, Ph.D., cofounder, will serve as Chief Scientific Officer. Under Glavin's leadership, Meissa aims to advance its AttenuBlock platform, focusing on intranasal vaccines for RSV and COVID-19. Current clinical data shows promising results for both vaccine candidates, with Phase 1 studies demonstrating safety and immunogenicity. The company is committed to tackling respiratory viral infections on a global scale.
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