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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 positive topline results from its ongoing Phase 1/2 COMPOSE Study of pegtibatinase, an investigational enzyme replacement therapy for classical homocystinuria (HCU). The highest dose cohort (1.5mg/kg BIW) showed a clinically meaningful 55.1% mean reduction in total homocysteine after 12 weeks, maintaining levels below 100 μmol. The treatment was well-tolerated with no discontinuations due to adverse events. The company plans to engage regulators for a pivotal development program to support potential approvals.
Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity grants totaling 71,350 shares to five new employees on December 10, 2021. This includes stock options for 58,500 shares and restricted stock units (RSUs) for 12,850 shares, granted outside the 2018 Equity Incentive Plan. The stock options have an exercise price of $26.76, vesting over four years, while RSUs also vest over four years, contingent on continued employment. These grants are part of the company’s strategy to attract talent within the biopharmaceutical sector.
SAN DIEGO, Nov. 11, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics (NASDAQ: TVTX) will present a company overview at two upcoming virtual investor conferences in November. The events are the Jefferies 2021 London Healthcare Conference on November 18, 2021, starting at 8:00 a.m. GMT, and the 4th Annual Evercore ISI HealthCONx Conference on November 30, 2021, at 10:30 a.m. ET. Live webcasts and archived replays will be available on their investor relations website for up to 30 days.
Travere Therapeutics (NASDAQ: TVTX) announced the presentation of non-clinical data on sparsentan, aimed at protecting kidney function in rare glomerular diseases, at the ASN Kidney Week 2021, from November 4-7, 2021. Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist, is under Phase 3 clinical trials for treating IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). The company achieved significant interim results, showing improvements in proteinuria levels. ePosters will be available online from November 4, 2021, through January 7, 2022.
Travere Therapeutics (TVTX) announced positive interim results from its Phase 3 PROTECT Study of sparsentan for IgA nephropathy, showing a 49.8% reduction in proteinuria compared to 15.1% for irbesartan (p<0.0001). After pre-NDA interactions with the FDA, an NDA submission for sparsentan's accelerated approval is expected in Q1 2022. Additionally, plans for a combined MAA for IgA nephropathy and FSGS in Europe are in place. Q3 2021 net product sales reached $54.2 million, up from $51.1 million in Q3 2020, while the company reported a net loss of $35.6 million for the quarter.
Travere Therapeutics (NASDAQ: TVTX) will announce its third quarter 2021 financial results on October 28, 2021, after 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 join the call by dialing +1 (855) 219-9219 (U.S.) or +1 (315) 625-6891 (International) with confirmation code 5068414. A replay will be available from October 28 until November 4, 2021. Travere aims to offer life-changing therapies for rare diseases.
Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity grants totaling 74,900 shares to 11 new employees on October 10, 2021. This includes stock options for 62,100 shares at an exercise price of $26.09 and 12,800 restricted stock units (RSUs). The options have a 10-year term and vest over four years, while the RSUs also vest over four years. These grants comply with Nasdaq Listing Rule 5635(c)(4) and are designed to attract new talent.
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.
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