Travere Therapeutics Inc Stock Price, News & Analysis

Travere Therapeutics (TVTX) will present seven abstracts at the ERA Congress in Vienna showcasing new data for FILSPARI in treating IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). Key findings include: The Phase 2 SPARTACUS Study showed FILSPARI provided meaningful benefits when replacing RASi in IgAN patients on SGLT2i therapy. The PROTECT Study's open-label extension demonstrated significant proteinuria reduction in patients switching from irbesartan to FILSPARI. Preclinical studies revealed FILSPARI's protective role against IgA deposition and its ability to maintain glomerular filtration barrier integrity. The DUPLEX Study showed patients achieved proteinuria remission faster and more frequently with FILSPARI compared to irbesartan. The presentations will take place June 4-7, 2025, highlighting FILSPARI's potential as a foundational therapy for rare kidney diseases.

CSL Vifor announced that FILSPARI® (sparsentan) has received recommendation from England's National Institute for Health and Care Excellence (NICE) for treating IgA nephropathy. The treatment is approved for adults with urine protein excretion ≥1.0 g/day or urine protein-to-creatinine ratio ≥0.75 g/g. This marks the first non-immunosuppressive dual-action therapy recommended for this condition, which affects over 22,000 adults in England. The recommendation follows MHRA authorization in April 2025, with commercial availability expected from July 2025. IgA nephropathy, the most common primary glomerular disease worldwide, leads to kidney failure in 30-40% of patients within 10 years of diagnosis if not properly controlled. The NICE decision requires NHS England to fund the treatment within 90 days of final publication, expected on June 27, 2025.

The FDA has accepted Travere Therapeutics' (NASDAQ: TVTX) supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) to treat focal segmental glomerulosclerosis (FSGS). The PDUFA target action date is set for January 13, 2026, with plans for an advisory committee meeting.

If approved, FILSPARI would become the first and only FDA-approved treatment for FSGS, a rare kidney condition leading to kidney failure. The drug is a non-immunosuppressive, oral medication targeting podocyte injury through ETAR and AT1R blockade. The sNDA is supported by the Phase 3 DUPLEX and Phase 2 DUET studies, which showed superior and sustained reductions in proteinuria compared to irbesartan, with a comparable safety profile.

Travere Therapeutics (NASDAQ: TVTX) announced the granting of inducement equity awards to six new employees on May 10, 2025. The Compensation Committee approved restricted stock units (RSUs) covering 35,900 shares of common stock. While granted outside of the company's 2018 Equity Incentive Plan, these RSUs follow the plan's terms and were awarded as employment inducements under Nasdaq Listing Rule 5635(c)(4). The RSUs feature a four-year vesting schedule, with 25% of shares vesting annually on the grant date anniversary, contingent on continued employment.

Travere Therapeutics (NASDAQ: TVTX) has announced its participation in three upcoming investor conferences in May and June 2025. The company will present at the BofA Securities 2025 Healthcare Conference on May 14 at 3:40 p.m. PT and the Jefferies Global Healthcare Conference on June 4 at 3:10 p.m. ET. Additionally, Travere will participate in the Scotiabank Third Annual Healthcare Canadian Investor Day on June 17. Live webcasts for the BofA and Jefferies presentations will be available on Travere's investor relations website, with replays accessible for 30 days after each event.

Travere Therapeutics (NASDAQ: TVTX) reported strong Q1 2025 financial results, highlighting significant growth in FILSPARI sales. Net product sales reached $75.9M, up from $40.0M in Q1 2024, driven by FILSPARI's commercial success in IgAN treatment. FILSPARI's U.S. sales totaled $55.9M with 703 new patient start forms received. The company reported a net loss of $41.2M ($0.47 per share), improved from a $136.1M loss in Q1 2024. Key developments include submission of sNDA for FILSPARI in FSGS treatment, conversion to full approval in Europe and UK for IgAN treatment, and strong cash position of $322.2M. Clinical data presented at the National Kidney Foundation Spring Clinical Meetings demonstrated FILSPARI's effectiveness, showing ~70% proteinuria reduction in newly diagnosed IgAN patients and supporting its position as a foundational kidney-targeted therapy.

Travere Therapeutics and CSL Vifor have achieved a significant milestone as the European Commission converts the conditional approval of FILSPARI to standard marketing authorization for treating IgA nephropathy (IgAN).

FILSPARI, the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe, is now authorized for adult patients with primary IgAN showing urine protein excretion ≥1.0 g/day. The approval spans all EU member states, Iceland, Liechtenstein, and Norway.

The decision follows positive results from the Phase 3 PROTECT Study, which showed FILSPARI significantly slowed kidney function decline compared to irbesartan over two years. The UK's MHRA has also converted FILSPARI's conditional approval to standard approval. The drug is currently available in Germany, Austria, and Switzerland.

Following this approval, Travere expects to receive a $17.5 million milestone payment from CSL Vifor, with additional milestone payments possible based on market access and sales achievements.

CSL Vifor and Travere Therapeutics have achieved a significant milestone as the European Commission converts the conditional approval of FILSPARI to standard marketing authorization for treating IgA Nephropathy (IgAN).

FILSPARI, the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN treatment, is currently available in Germany, Austria, and Switzerland. The approval covers all EU member states, Iceland, Liechtenstein, and Norway.

The decision follows positive phase-III PROTECT study results, which showed FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. The drug is approved for adults with primary IgA nephropathy with specific urine protein excretion levels.

This standard approval, granted without changes to the indication, validates the clinical data and marks an important advancement for IgAN patients across Europe.

Travere Therapeutics (NASDAQ: TVTX) has scheduled its first quarter 2025 financial results announcement for Thursday, May 1, 2025, after U.S. financial markets close. The company will follow the earnings release with 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 details through Travere's investor relations website at ir.travere.com/events-and-presentations. A replay of the webcast will remain available on the company's website for 30 days following the live presentation.