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.
Travere Therapeutics (Nasdaq: TVTX) has announced plans for an underwritten public offering of its common stock. The company will offer all shares, with an additional 30-day option for underwriters to purchase up to 15% more shares. Jefferies and Leerink Partners are serving as joint book-running managers. The offering will be made pursuant to an automatically effective shelf registration statement filed with the SEC on August 1, 2024. The completion, size, and terms of the offering are subject to market conditions and cannot be assured.
Travere Therapeutics (NASDAQ: TVTX) has announced its participation in two major healthcare investor conferences this November. The company will present at the Guggenheim Securities Healthcare Innovation Conference on Monday, November 11, 2024, at 2:30 p.m. ET, and at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024, at 8:30 a.m. GMT. Live webcasts of both presentations will be available on Travere's investor relations website, with replays accessible for up to 30 days after each event.
Travere Therapeutics (NASDAQ: TVTX) reported Q3 2024 financial results, highlighting FILSPARI's full FDA approval as the only non-immunosuppressive treatment for IgAN. Net product sales reached $61.0 million, with FILSPARI contributing $35.6 million. Total revenue was $62.9 million. The company received 505 new patient start forms for FILSPARI during Q3. R&D expenses decreased to $51.7 million from $60.6 million year-over-year. The company reported a net loss of $54.8 million ($0.70 per share) and held $277.4 million in cash and equivalents as of September 30, 2024.
Travere Therapeutics presented new data for FILSPARI (sparsentan) at ASN Kidney Week 2024, showing significant clinical benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). The SPARTAN Study demonstrated nearly 60% of first-line IgAN patients achieved complete remission, with approximately 70% proteinuria reduction over 24 weeks. The SPARTACUS Study showed FILSPARI's effectiveness in combination therapy, with one-third of patients achieving 50% proteinuria reduction when added to SGLT2i. In genetic FSGS patients, typically treatment-resistant, FILSPARI delivered sustained proteinuria reduction and long-term kidney health benefits.
Travere Therapeutics (NASDAQ: TVTX) has announced its plans to report third quarter 2024 financial results on Thursday, October 31, 2024, before the U.S. financial markets open. The company will host a conference call and webcast at 8:30 a.m. ET to discuss the financial results and provide a general business update.
Investors and interested parties can access the webcast and dial-in information on the Investor page of Travere's website at ir.travere.com/events-presentations. An archived version of the call will be available for 30 days on the company's website following the live webcast.
Travere Therapeutics and CSL Vifor have announced that Swissmedic has granted temporary marketing authorization for FILSPARI® (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with specific urine protein excretion levels. The approval is based on results from the Phase 3 PROTECT Trial, which showed statistically significant and clinically meaningful outcomes.
FILSPARI offers a once-daily, oral, non-immunosuppressive treatment that targets kidney damage directly and has demonstrated superior results compared to maximally dosed irbesartan. This approval follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. Both companies express enthusiasm about providing access to this innovative treatment for the Swiss IgAN community.
CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.
Travere Therapeutics (Nasdaq: TVTX) will present 11 abstracts at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, CA, from October 23-27, 2024. The presentations will showcase new data on FILSPARI® (sparsentan), the only approved kidney-targeted medicine for IgA nephropathy (IgAN).
Key highlights include:
- Efficacy and safety results of FILSPARI as a first-line treatment in newly diagnosed IgAN patients (SPARTAN Study)
- Analysis of FILSPARI's clinical benefit in IgAN regardless of baseline proteinuria (PROTECT Study)
- Patient-reported outcomes from the PROTECT and DUPLEX Studies
- Data on FILSPARI in combination with SGLT2 inhibitors
- A late-breaking presentation on outcomes in patients with genetic focal segmental glomerulosclerosis (gFSGS) from the DUPLEX Study
The presentations will cover various aspects of FILSPARI's use in IgAN and FSGS, including its efficacy as a first-line treatment and in combination with other therapies.
Travere Therapeutics (Nasdaq: TVTX) has announced a voluntary pause in enrollment for its Phase 3 HARMONY Study of pegtibatinase, a potential treatment for classical homocystinuria (HCU). This decision was made to address necessary process improvements in manufacturing scale-up for commercial production. Currently enrolled patients will continue to receive study medication from unaffected small-scale batches.
The pause was initiated after the company determined that the desired drug substance profile was not achieved in the recent scale-up process. Travere expects to restart enrollment in the HARMONY Study no earlier than 2026. As a result, the company anticipates a reduction in research and development expenses by more than $30 million in 2025 compared to 2024. Travere's cash reserves of $325.4 million as of June 30, 2024, are expected to support operations into 2028.
Travere Therapeutics (NASDAQ: TVTX) announced that on September 10, 2024, its Compensation Committee granted inducement equity grants to six new employees. These grants consist of restricted stock units (RSUs) covering a total of 33,500 shares of common stock. The RSUs were granted outside of Travere's 2018 Equity Incentive Plan but are subject to its terms. They were provided as inducements for new employees joining Travere, in compliance with Nasdaq Listing Rule 5635(c)(4). The RSUs have a four-year vesting schedule, with 25% of the shares vesting annually on the grant date anniversary, contingent on the employee's continued service with Travere.
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