Travere Therapeutics Inc Stock Price, News & Analysis

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.

Travere Therapeutics (NASDAQ: TVTX) has announced the granting of inducement equity awards to six new employees by its Board's Compensation Committee on April 10, 2025. The grants consist of restricted stock units (RSUs) covering 31,100 shares of common stock.

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

Travere Therapeutics (TVTX) announced three presentations at the upcoming National Kidney Foundation Spring Clinical Meetings 2025 in Boston. The highlight is a late-breaking oral presentation featuring new analyses from the Phase 3 DUPLEX Study of FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS).

Key findings show that FILSPARI achieved partial and complete proteinuria remission more quickly and frequently compared to irbesartan, with patients showing low rates of kidney failure. Additional presentations include data from the Phase 2 SPARTAN Study demonstrating FILSPARI's effectiveness as first-line treatment in newly diagnosed IgA nephropathy (IgAN) patients, showing rapid proteinuria reduction and decreased sCD163 inflammatory biomarker levels.

The presentations will take place on April 10, 2025, including real-world case studies highlighting FILSPARI's effectiveness across various IgAN patient backgrounds, particularly those with high proteinuria and prior treatments.

Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking priority review for FILSPARI® (sparsentan) to treat focal segmental glomerulosclerosis (FSGS). The submission is backed by Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated FILSPARI's superior efficacy in reducing proteinuria compared to irbesartan in both adults and children.

FILSPARI, a non-immunosuppressive oral medication targeting podocyte injury, could become the first FDA-approved treatment for FSGS, a rare kidney condition and leading cause of kidney failure. The drug is currently approved for IgA nephropathy to slow kidney function decline.

The FDA has 60 days to accept the application for review, with a decision expected in Q2 2025. Additionally, the FDA has deemed REMS monitoring for embryo-fetal toxicity no longer necessary, and the company plans to submit an amendment to modify liver monitoring requirements, with a PDUFA target date of August 28, 2025.

Travere Therapeutics (NASDAQ: TVTX) has announced the granting of inducement equity awards to five new employees on March 10, 2025. The compensation package includes:

• 36,000 shares in stock options with an exercise price of $17.87 per share
• 41,200 restricted stock units (RSUs)

The stock options are non-qualified, have a 10-year term, and vest over four years with 25% vesting after one year and the remaining 75% vesting monthly over 36 months. The RSUs vest over four years, with 25% vesting annually. These grants were made outside the company's 2018 Equity Incentive Plan but are subject to its terms, awarded as employment inducements under Nasdaq Listing Rule 5635(c)(4).

Travere Therapeutics (NASDAQ: TVTX) has announced its participation in four major investor conferences during March 2025. The company will present at the TD Cowen 45th Annual Health Care Conference on March 3 at 9:10 a.m. ET and the Leerink Partners Global Biopharma Conference on March 11 at 9:20 a.m. ET. Additional appearances include the Barclays 27th Annual Global Healthcare Conference and Jefferies Biotech on the Beach Summit, both scheduled for March 12.

Live webcasts will be available for the TD Cowen and Leerink Partners conference presentations through Travere's investor relations website at ir.travere.com/events-presentations. These webcasts will remain accessible for replay up to 30 days after each event.

Travere Therapeutics (NASDAQ: TVTX) reported strong financial results for Q4 and full year 2024. Net product sales reached $73.5 million in Q4 2024 (up from $39.9 million in Q4 2023) and $226.7 million for full year 2024 (up from $127.5 million in 2023). FILSPARI sales contributed $49.6 million in Q4 and $132.2 million for the full year.

The company plans to submit an sNDA around the end of Q1 2025 seeking traditional approval of FILSPARI for FSGS. The FDA granted full approval to FILSPARI in September 2024 for slowing kidney function decline in adults with primary IgAN. The company received 693 new patient start forms in Q4 2024.

As of December 31, 2024, Travere had cash, cash equivalents, and marketable securities of $370.7 million, including $134.7 million from a November 2024 common stock offering.