Travere Therapeutics Inc Stock Price, News & Analysis

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.

Travere Therapeutics (NASDAQ: TVTX) provided a regulatory update on its sparsentan program for focal segmental glomerulosclerosis (FSGS). Following successful interim results from the Phase 3 DUPLEX Study, the FDA indicated that the data was insufficient for accelerated approval this year. The company remains optimistic about future submissions pending additional data expected in 2022. Meanwhile, initial discussions with the EMA supported a conditional marketing authorization submission planned for late 2021. Results from the confirmatory endpoint are anticipated in 2023.

Travere Therapeutics (TVTX) reported first-quarter 2021 financial results, highlighting net product sales of $47.4 million, slightly down from $47.8 million YoY. The company achieved a significant milestone by completing the interim endpoint in the DUPLEX Study of sparsentan for FSGS and is pursuing accelerated approval from regulators. The PROTECT Study for IgA nephropathy is nearing full enrollment, with topline data expected in Q3 2021. Cash and equivalents stood at $520.9 million as of March 31, 2021. Despite increased R&D and SG&A expenses, the company remains optimistic about future growth.