Travere Therapeutics, Inc. - TVTX STOCK NEWS

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.

Travere Therapeutics (NASDAQ: TVTX) announced that CEO Eric Dube, Ph.D., will present at the BofA Securities 2021 Virtual Health Care Conference on May 11, 2021, at 5:00 p.m. ET. A live webcast of the presentation will be available on the company's investor relations page and an archived replay will be accessible for 30 days thereafter.

The company is dedicated to addressing the urgent treatment needs of patients with rare diseases and aims to deliver impactful therapies in collaboration with the rare disease community.

Travere Therapeutics (NASDAQ: TVTX) will announce its Q1 2021 financial results on May 6, 2021, after U.S. market close. A conference call is scheduled for the same day at 4:30 p.m. ET, aimed at discussing the results and providing a business update. Interested participants can join via dial-in or a live webcast on Travere's investor relations site. A replay will be accessible from 7:30 p.m. ET on May 6 to 7:30 p.m. ET on May 13.

Travere Therapeutics (TVTX) announced strong performance in its fourth quarter and full year 2020 financial results, with net product sales increasing by 13% year-over-year to $198 million. The company reported a net loss of $121.6 million for Q4 2020, compared to $30.3 million in Q4 2019. Key developments include achieving the interim endpoint in the DUPLEX Study for FSGS and plans to report data from the PROTECT Study for IgAN in Q3 2021. The company’s cash position stands at $361.6 million, boosted by a recent stock offering generating $189 million in proceeds.

Travere Therapeutics (NASDAQ: TVTX) participates in Rare Disease Day 2021, honoring over 400 million individuals worldwide affected by rare diseases. CEO Eric Dube emphasizes their commitment to improving patient outcomes and community access to treatment. The company supports various organizations tackling healthcare inequities and promoting innovation in rare diseases. The National Burden of Rare Disease Study, expected to release economic impact findings on February 25, aims to raise awareness and inform policy changes. Travere will host an internal event on February 26 to celebrate this initiative.

Travere Therapeutics (NASDAQ: TVTX) has announced its participation in two upcoming virtual investor conferences. The first is the SVB Leerink 10th Annual Global Healthcare Conference on February 24, 2021, at 1:00 p.m. ET. The second is the Barclays Global Healthcare Conference on March 10, 2021, at 11:30 a.m. ET. Live webcasts and archived replays will be available for 30 days on their website. Travere focuses on developing therapies for rare diseases, engaging with the community to understand their needs and deliver impactful treatments.

Travere Therapeutics (NASDAQ: TVTX) has received orphan designation from the European Commission for sparsentan, targeting IgA nephropathy (IgAN), a rare kidney disorder that can lead to end-stage kidney disease. Sparsentan, currently in pivotal Phase 3 trials for both IgAN and focal segmental glomerulosclerosis (FSGS), achieved its interim proteinuria endpoint in the DUPLEX Study. The company aims to set a new treatment standard for IgAN and indicates positive early results. Orphan designation grants a 10-year marketing exclusivity and various incentives in the EU.

Travere Therapeutics has completed an underwritten public offering of 7,532,500 shares of its common stock at $26.75 per share, raising approximately $201.5 million in gross proceeds. The offering included 982,500 shares from the full exercise of underwriters’ options. The shares were sold under an effective shelf registration statement filed with the SEC. The offering was managed by BofA Securities, Jefferies, and SVB Leerink.