Travere Therapeutics Inc Stock Price, News & Analysis

Travere Therapeutics (Nasdaq: TVTX) announced that the FDA will no longer require an advisory committee meeting for the supplemental New Drug Application (sNDA) of FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The PDUFA target action date remains January 13, 2026.

The sNDA is supported by the Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated FILSPARI's superior efficacy in reducing proteinuria compared to irbesartan. Notably, patients achieving proteinuria remission showed a 67% to 77% lower risk of kidney failure. If approved, FILSPARI would become the first medication specifically indicated for FSGS treatment.

Travere Therapeutics (Nasdaq: TVTX) presented long-term safety and efficacy data for pegtibatinase in treating classical homocystinuria (HCU) at the International Congress of Inborn Errors of Metabolism in Kyoto, Japan.

The Phase 1/2 COMPOSE open-label extension study showed that patients receiving the target dose of 2.5 mg/kg twice weekly maintained significant metabolite reductions over 50 weeks, including a 53.5% reduction in total homocysteine and a 67.1% reduction in methionine. Notably, homocysteine levels remained below the clinical guideline threshold of 100 µM, and the treatment was generally well-tolerated with no new safety concerns.

The company plans to restart enrollment in the Phase 3 HARMONY Study evaluating pegtibatinase for classical HCU treatment in 2026.

Travere Therapeutics (Nasdaq: TVTX) announced that the FDA has approved significant modifications to the Risk Evaluation and Mitigation Strategy (REMS) for FILSPARI® (sparsentan), their treatment for IgA nephropathy (IgAN). The key changes include reducing liver function monitoring from monthly to every three months and completely removing the embryo-fetal toxicity monitoring requirement.

The simplified monitoring requirements were supported by safety data from post-marketing surveillance and multiple clinical studies, including the Phase 3 PROTECT Study in IgAN, Phase 3 DUPLEX Study, and Phase 2 DUET Study in FSGS. Additionally, a supplemental New Drug Application (sNDA) for FILSPARI in FSGS is under FDA review with a PDUFA date of January 13, 2026.

Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity awards to nine new employees on August 10, 2025. The grants consist of restricted stock units (RSUs) covering 45,100 shares of common stock. These RSUs were granted outside the company's 2018 Equity Incentive Plan but are subject to its terms.

The RSUs will vest over four years, with 25% of shares vesting annually on the grant date anniversary, contingent on continued employment with Travere. The grants were made as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4).

Travere Therapeutics (NASDAQ: TVTX) reported strong Q2 2025 financial results, highlighted by significant growth in FILSPARI sales. The company achieved total revenue of $114.4 million, including net product sales of $94.8 million. FILSPARI's U.S. net sales grew 165% year-over-year to $71.9 million, with 745 new patient start forms received.

Key developments include FDA acceptance of FILSPARI's sNDA for FSGS with a PDUFA date of January 13, 2026, and an upcoming PDUFA date of August 28, 2025, for REMS modification in IgAN treatment. The company ended Q2 with $319.5 million in cash and equivalents. Net loss improved to $12.8 million ($0.14 per share) compared to $70.4 million in Q2 2024.

Travere Therapeutics (NASDAQ: TVTX) has announced its participation in four upcoming investor conferences in August and September 2025. The company will present at the Canaccord Genuity Growth Conference (August 13), Citi's Biopharma Back to School Conference (September 2), Wells Fargo Healthcare Conference (September 3), and Cantor Global Healthcare Conference (September 4).

All presentations will be available via live webcast on Travere's investor relations website, with replays accessible for 30 days after each event.

Travere Therapeutics (NASDAQ: TVTX) has scheduled its second quarter 2025 financial results announcement for Wednesday, August 6, 2025, after U.S. markets close. The company will host a conference call and webcast at 4:30 p.m. ET to discuss the results and provide a business update.

Investors can access the webcast and dial-in information through Travere's investor relations website at ir.travere.com/events-and-presentations. A replay of the webcast will be available on the company's website for 30 days following the live presentation.

Travere Therapeutics (NASDAQ: TVTX) announced inducement equity grants for 17 new employees. The grants consist of restricted stock units (RSUs) covering 121,700 shares of common stock. These RSUs were granted outside the company's 2018 Equity Incentive Plan but are subject to its terms, in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over four years, with 25% of shares vesting annually on the grant date anniversary, contingent on continued employment with Travere.

Travere Therapeutics (NASDAQ: TVTX) announced that its Board's Compensation Committee has granted inducement equity awards to 15 new employees on June 10, 2025. The grants consist of restricted stock units (RSUs) covering 81,100 shares of common stock. These RSUs were granted outside of the company's 2018 Equity Incentive Plan but are subject to its terms, serving as material inducements for new employee recruitment in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over a four-year period, with 25% of shares vesting annually on the grant date anniversary, contingent on continued employment with Travere.