Travere Therapeutics Inc Stock Price, News & Analysis

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.