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 (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.
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.
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