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 the grant of inducement equity covering 173,000 shares to 12 new employees on November 10, 2022. This includes inducement stock options for 90,000 shares and restricted stock units (RSUs) for 83,000 shares, granted outside the 2018 Equity Incentive Plan to comply with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $22.11 per share, vesting over four years, while the RSUs will also vest over the same period, contingent on continued service with the company.
Travere Therapeutics has launched the RKD & Me campaign in partnership with the IgA Nephropathy Foundation and NephCure Kidney International. The campaign aims to raise awareness of rare kidney disease (RKD) by sharing personal stories from those affected. Approximately 60-80 individuals per 100,000 in the U.S. are living with RKD, often facing challenges in diagnosis and support due to low public awareness. The initiative includes a platform for the RKD community to share their experiences and insights, helping to foster understanding and connection.
Travere Therapeutics (NASDAQ: TVTX) will participate in several key healthcare conferences in November and December 2022. Key events include:
- Jefferies 2022 London Healthcare Conference on November 16 at 4:25 p.m. GMT.
- 5th Annual Evercore ISI HealthCONx Conference on November 29 at 1:25 p.m. ET.
- Piper Sandler Healthcare Conference on December 1 at 10:30 a.m. ET.
- BofA Securities 2022 Biotech SMID Cap Conference on December 7 at 12:15 p.m. ET.
Live webcasts will be accessible on the company’s website.
Travere Therapeutics (TVTX) announced major developments in its drug pipeline and financial results for Q3 2022. The EMA has accepted the CMA application for sparsentan for IgAN, with a decision expected in H2 2023. The FDA has extended the PDUFA date to February 17, 2023. Q3 net product sales reached $50.8 million, down from $54.2 million YoY, contributing to total revenue of $53.5 million. R&D expenses increased to $59.3 million. The company reported a net loss of $69.7 million. Cash reserves stood at $506.3 million, supporting ongoing programs in rare kidney diseases.
Travere Therapeutics (NASDAQ: TVTX) announced presentations at the ASN Kidney Week 2022, detailing long-term clinical data for svarsentan in treating focal segmental glomerulosclerosis (FSGS) and insights into IgA nephropathy (IgAN). The studies include a 240-week analysis of the DUET Study, showcasing sparsentan's efficacy and safety. With Orphan Drug Designation granted, sparsentan aims for FDA accelerated approval, potentially being the first approved treatment for both FSGS and IgAN. Presentations will occur from November 3-6, 2022, in Orlando, Florida.
Travere Therapeutics (NASDAQ: TVTX) will report its third quarter 2022 financial results on October 27, 2022, after market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a general business update. Investors can access the call via dial-in numbers or through a live webcast on the company's website, with a replay available post-event. Travere focuses on developing treatments for patients with rare diseases, aiming to address urgent treatment needs through collaboration with the rare disease community.
On October 13, 2022, Travere Therapeutics (NASDAQ: TVTX) announced a likely three-month extension of the PDUFA target action date for its NDA for sparsentan, a treatment for IgA nephropathy, originally set for November 17, 2022. Following discussions with the FDA, the company was asked to revise its Risk Evaluation Mitigation Strategy (REMS) to include liver monitoring. This update is expected to be a major amendment requiring additional review time, but no new clinical data was requested. The company remains confident in sparsentan's efficacy based on robust clinical data.
On October 10, 2022, Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity grants to seven new employees. These inducement restricted stock units (RSUs) cover a total of 25,750 shares of common stock and are part of Travere's 2018 Equity Incentive Plan. The RSUs will vest over four years, with 25% vesting on each anniversary of the grant date, contingent upon the employees' continued service. This move aligns with Nasdaq Listing Rule 5635(c)(4), aimed at attracting talent essential for the company's operations.
Travere Therapeutics (NASDAQ: TVTX) announced on September 10, 2022, that its Board of Directors granted inducement restricted stock units (RSUs) covering 79,600 shares to 16 new employees. These RSUs, awarded outside the 2018 Equity Incentive Plan, are part of an effort to attract talent in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs vest over four years, with 25% vesting annually based on continued service with the company.
Travere Therapeutics (NASDAQ: TVTX) announced a presentation at the Society for the Study of Inborn Errors of Metabolism Annual Symposium in Freiburg, Germany, from August 30 to September 2, 2022. The focus will be on a genetic evaluation and cognitive function analysis from a longitudinal study related to classical homocystinuria (HCU). The study includes population-based estimates of HCU incidence and will showcase investigational enzyme replacement therapy, pegtibatinase, currently in Phase 1/2 trials. Authors will present findings during the poster walk on August 31, with details available electronically.
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