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.
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.
Travere Therapeutics (NASDAQ: TVTX) announced presentations on nonclinical data of sparsentan at the 58th ERA-EDTA Congress, focusing on its renal protective effects in focal segmental glomerulosclerosis (FSGS) mouse models. Key findings include analyses revealing significant treatment effects in proteinuria reduction for FSGS and IgA nephropathy. The company is currently conducting pivotal Phase 3 studies for sparsentan, which has shown statistical significance in achieving its interim endpoint of reduced proteinuria, suggesting promising potential for regulatory approval for both conditions.
Travere Therapeutics announced the completion of patient enrollment in the Phase 3 PROTECT Study for sparsentan, targeting IgA nephropathy. This pivotal study aims to assess the drug's safety and efficacy in approximately 380 patients, with topline data for the interim 36-week proteinuria endpoint expected in August 2021. Sparsentan could potentially become a non-immunosuppressant treatment option for this severe kidney disorder, which currently has no approved therapies.
Travere Therapeutics (NASDAQ: TVTX) will present at upcoming virtual investor conferences throughout June 2021. Key events include:
- Jefferies Virtual Healthcare Conference on June 2 at 1:00 p.m. ET
- JMP Securities Life Sciences Conference on June 16 at 11:00 a.m. ET
- BMO Biopharma Day on June 22 at 11:15 a.m. ET
Live webcasts will be available on their website, and archived replays can be accessed for up to 30 days. Travere is dedicated to developing therapies for rare diseases and aims to support patients and families affected by these conditions.
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