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. (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 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.
SAN DIEGO, May 3, 2022 (GLOBE NEWSWIRE) - Travere Therapeutics (NASDAQ: TVTX) announced that CEO Eric Dube, Ph.D., will present at the BofA Securities 2022 Healthcare Conference on May 10, 2022, at 4:00 p.m. PT. A live webcast of the presentation will be available, along with an archived replay accessible for 30 days post-event.
Travere Therapeutics focuses on developing therapies for patients with rare diseases, emphasizing the need for urgent treatment options and collaboration with the rare disease community.
Travere Therapeutics (NASDAQ: TVTX) plans to release its first quarter 2022 financial results on May 5, 2022, following the U.S. market close. A conference call and webcast to discuss these results and provide a business update is scheduled for 4:30 p.m. ET.
Investors can join the call using the provided dial-in numbers, and a replay will be accessible from 7:30 p.m. ET on May 5 until 7:30 p.m. ET on May 12.
Travere Therapeutics (NASDAQ: TVTX) announced that CFO Laura Clague will retire in August 2022 after seven years, transitioning to an advisory role until 2023. Chris Cline, current SVP of Investor Relations & Corporate Communications, will succeed her, effective the same month. CEO Eric Dube praised Clague's contributions that established a strong financial position for the company. Cline, a finance expert with over 15 years in the industry, is expected to enhance the company’s growth phase and strengthen its commitment to the rare disease community.
Travere Therapeutics (NASDAQ: TVTX) announced on April 10, 2022, that its Compensation Committee granted 13 new employees inducement equity grants. These grants consist of 51,750 restricted stock units (RSUs), which are tied to the company’s 2018 Equity Incentive Plan. The RSUs will vest over four years, with 25% vesting each year, contingent on the employees maintaining their service relationship with the company. This initiative aims to attract talent crucial for advancing Travere's mission in rare disease therapies.
Travere Therapeutics (NASDAQ: TVTX) announced the presentation of data from its ongoing Phase 1/2 COMPOSE Study of pegtibatinase, an investigational enzyme replacement therapy for classical homocystinuria (HCU), at two significant conferences. The SIMD 43rd Annual Meeting will take place from April 10-13, 2022, in Orlando, FL, while the 2022 GMDI Conference is scheduled for May 4-7, 2022, in Lake Las Vegas, NV. Initial results have shown a 55.1% mean reduction in total homocysteine levels. Current HCU treatments are limited, highlighting the need for innovative therapies like pegtibatinase.
Eikon Therapeutics has appointed Dr. Roy D. Baynes as Executive Vice President and Chief Medical Officer, effective July 11, 2022. Dr. Baynes, a distinguished oncologist with extensive experience, previously held senior roles at Merck and Amgen, contributing to the development of significant drugs like Keytruda. He will lead the company's clinical research and development, leveraging Eikon's advanced technologies in drug discovery. This appointment aims to strengthen Eikon's ability to deliver innovative therapies for serious illnesses.
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