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 (NASDAQ: TVTX) announced a transition for its chief medical officer, Dr. Noah Rosenberg, to an advisory role by the end of 2021 for personal reasons. Dr. Rosenberg will assist with clinical trial oversight and regulatory submissions throughout 2022. The company has commenced the search for his successor while continuing its clinical programs. CEO Eric Dube praised Dr. Rosenberg's contributions to the ongoing pivotal Phase 3 studies of sparsentan, which are aimed at treating rare diseases.
The collaboration between Travere Therapeutics (TVTX) and Vifor Pharma aims to commercialize sparsentan, a potential first-in-class treatment for rare kidney disorders FSGS and IgAN. Under the agreement, Vifor obtains exclusive rights in Europe, Australia, and New Zealand, while Travere receives a USD 55 million upfront payment and could earn up to USD 135 million in milestone payments. Sparsentan is currently undergoing pivotal phase-III trials and has Orphan Drug Designation in both the U.S. and Europe for these conditions.
Travere Therapeutics (NASDAQ: TVTX) has entered a licensing agreement with Vifor Pharma for exclusive commercialization rights to sparsentan in Europe, Australia, and New Zealand. Travere will receive a $55 million upfront payment and could earn up to $135 million in milestone payments, along with tiered royalties of up to 40% on net sales. Sparsentan is being developed as a potential first-in-class treatment for the rare kidney disorders FSGS and IgAN. This collaboration aims to address significant unmet medical needs in these conditions.
Ruth Williams-Brinkley has been appointed to the Board of Directors of Travere Therapeutics (NASDAQ: TVTX), effective immediately. With over 35 years of experience in healthcare, she previously served as President of the Kaiser Foundation Health Plan for the Mid-Atlantic States. Williams-Brinkley aims to enhance the company’s efforts in delivering new treatment options for rare kidney conditions. The appointment is seen as a strategic move to bolster leadership as Travere advances its commercial pipeline.
Travere Therapeutics (NASDAQ: TVTX) announced on September 10, 2021, the grant of inducement equity grants totaling 48,100 shares of common stock to five new employees. This includes stock options for 40,500 shares and restricted stock units (RSUs) for 7,600 shares, all under the 2018 Equity Incentive Plan. The options have an exercise price of $23.55 per share and vest over four years, while the RSUs also vest over the same period. The granting was made to incentivize new hires in compliance with Nasdaq Listing Rule 5635(c)(4).
Travere Therapeutics (NASDAQ: TVTX) announced a successful Type A meeting with the FDA regarding the accelerated approval pathway for its drug sparsentan, aimed at treating focal segmental glomerulosclerosis (FSGS). The company plans to submit additional eGFR data from the DUPLEX Study in mid-2022, with hopes of demonstrating long-term benefits. Notably, sparsentan has shown statistical significance in interim results, and if approved, it could be the first treatment for both FSGS and IgAN.
Travere Therapeutics announced positive interim results from the pivotal Phase 3 PROTECT Study of sparsentan, showing a 49.8% mean reduction in proteinuria after 36 weeks, significantly surpassing the active comparator (15.1%) with a p-value of <0.0001. The drug has shown a favorable safety profile, and the company plans to submit an NDA for accelerated approval in the first half of 2022. This study involves 404 patients with IgA nephropathy, marking a significant advancement in treatment options for this rare kidney disorder.
Travere Therapeutics (TVTX) reported Q2 2021 net product sales of $54.6 million, up from $48.4 million in Q2 2020. The company is on track to submit a conditional marketing authorization application for sparsentan for FSGS in Europe by year-end 2021. The pivotal PROTECT Study for IgA nephropathy is set to deliver topline data in August 2021. R&D expenses rose to $51.8 million, while SG&A remained stable at $35.0 million. Net loss for Q2 was $39.0 million, or $0.64 per share, compared to a loss of $26.1 million a year prior.
Travere Therapeutics (NASDAQ: TVTX) will announce its Q2 2021 financial results on July 29, 2021, after U.S. market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a business update. Investors can participate via the provided dial-in numbers or access the live webcast on the company's website. A replay will be available until August 5, 2021.
Travere Therapeutics (NASDAQ: TVTX) announced the grant of inducement equity awards totaling 89,950 shares to eleven new employees on July 10, 2021. This includes stock options for 65,100 shares and restricted stock units (RSUs) covering 24,850 shares, granted outside the 2018 Equity Incentive Plan. The stock options have an exercise price of $14.68 and a 10-year term, vesting over four years. The RSUs also vest over four years. This initiative aims to attract talent critical for advancing its mission in rare disease treatments.
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