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) 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.
On June 10, 2022, Travere Therapeutics (NASDAQ: TVTX) awarded inducement equity grants to ten new employees, comprising 48,750 restricted stock units (RSUs). These RSUs, granted outside the 2018 Equity Incentive Plan, will vest over four years with 25% vesting each year, contingent on continued employment. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract new talent, enhancing the company's capabilities in developing therapies for rare diseases.
Travere Therapeutics (NASDAQ: TVTX) will present at the 2022 Jefferies Healthcare Conference on June 9, 2022, at 10:30 a.m. ET. A live webcast of the presentation will be accessible via their website, with a replay available for 30 days afterward. The company is dedicated to supporting individuals with rare diseases by developing crucial therapies in collaboration with the rare disease community. Travere aims to provide hope and effective treatment options for patients and families worldwide.
Travere Therapeutics announced key presentations at the 59th ERA Congress showcasing ongoing Phase 3 studies of sparsentan for IgA nephropathy and focal segmental glomerulosclerosis. The PROTECT study involves 404 patients and demonstrated a significant proteinuria reduction of 49.8% with sparsentan versus 15.1% for irbesartan. Meanwhile, the DUPLEX study, with 371 participants, reported a 42% achievement rate of FSGS remission with sparsentan. Both studies are fully enrolled, with topline results expected in 2023.
Travere Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for sparsentan to treat IgA nephropathy (IgAN) and granted it Priority Review, with a PDUFA target action date of November 17, 2022. If approved, sparsentan would be the first non-immunosuppressive treatment for IgAN, addressing a significant unmet need. The NDA is supported by positive interim results from the Phase 3 PROTECT Study, showing a 49.8% reduction in proteinuria after 36 weeks of treatment, with sparsentan well-tolerated among participants.
Travere Therapeutics (NASDAQ: TVTX) announced on May 10, 2022, the grant of inducement restricted stock units (RSUs) to 15 new employees, covering a total of 91,000 shares. This grant was made outside the 2018 Equity Incentive Plan to encourage new hires, aligning with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% vesting each year, contingent on the employees' continued service. This move underscores Travere's commitment to attracting talent as it focuses on developing treatments for rare diseases.
Travere Therapeutics (TVTX) reported its Q1 2022 results, with total revenue of $48.5 million, slightly down from $47.4 million in Q1 2021, due to decreased Thiola sales. R&D expenses increased to $56.6 million, driven by ongoing pivotal studies for sparsentan. The company reported a net loss of $76.0 million ($1.20 per share), compared to a $53.9 million loss in the prior year. The NDA for sparsentan in IgA nephropathy was submitted, with FDA acceptance expected soon. Cash reserves were strong at $603.4 million.