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.
News and updates for Travere Therapeutics, Inc. (TVTX) center on its work as a biopharmaceutical company focused on rare kidney, liver and metabolic diseases. Company announcements frequently highlight progress with FILSPARI (sparsentan), an oral, non-immunosuppressive therapy approved to slow kidney function decline in adults with primary IgA nephropathy (IgAN), and under supplemental FDA review as a potential treatment for focal segmental glomerulosclerosis (FSGS).
Investors following TVTX news can track regulatory milestones such as FDA review timelines, PDUFA target action dates and review extensions for the FILSPARI sNDA in FSGS. Travere also reports new clinical data from the Phase 3 DUPLEX and Phase 2 DUET studies in FSGS, as well as from PROTECT, SPARTAN and real-world analyses in IgAN. These updates often focus on proteinuria reduction, kidney function outcomes and correlations between biomarker changes and long-term kidney failure risk.
Travere’s news flow includes financial results and preliminary revenue updates, typically furnished via press releases and Form 8‑K filings, along with commentary on commercial performance of FILSPARI in IgAN. The company also issues releases on pipeline developments, including the planned restart of the pivotal Phase 3 HARMONY Study of pegtibatinase for classical homocystinuria (HCU) and long-term metabolite reduction data from the COMPOSE study.
Additional news items cover partnership activities with CSL Vifor and Renalys Pharma, anticipated regional filings and launches, and Travere’s participation in major medical and investor conferences such as the American Society of Nephrology Kidney Week and large healthcare investment meetings. This page aggregates these developments so readers can follow how clinical, regulatory, commercial and partnership events may shape the company’s rare disease portfolio over time.
SAN DIEGO, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics (NASDAQ: TVTX) announced that Eric Dube, Ph.D., CEO, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on January 12, 2023, at 11:15 a.m. PT. A live webcast will be available on the company's website, with an archived replay accessible for 30 days.
Travere Therapeutics focuses on developing therapies for rare diseases, collaborating with the community to understand patient needs and deliver impactful treatments.
Travere Therapeutics (NASDAQ: TVTX) announced the grant of inducement equity awards covering 124,100 shares to 11 new employees. This includes inducement stock options for 65,000 shares and 59,100 restricted stock units (RSUs). The stock options have an exercise price of $18.90 per share and vest over four years. The RSUs also vest over four years with similar terms. These grants were made outside the 2018 Equity Incentive Plan as a condition of employment, compliant with Nasdaq Listing Rule 5635(c)(4).
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.