Travere Therapeutics, Inc. - TVTX STOCK NEWS

Travere Therapeutics and CSL Vifor have announced that Swissmedic has granted temporary marketing authorization for FILSPARI® (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with specific urine protein excretion levels. The approval is based on results from the Phase 3 PROTECT Trial, which showed statistically significant and clinically meaningful outcomes.

FILSPARI offers a once-daily, oral, non-immunosuppressive treatment that targets kidney damage directly and has demonstrated superior results compared to maximally dosed irbesartan. This approval follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.

In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. Both companies express enthusiasm about providing access to this innovative treatment for the Swiss IgAN community.

CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.

Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.

Travere Therapeutics (Nasdaq: TVTX) will present 11 abstracts at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, CA, from October 23-27, 2024. The presentations will showcase new data on FILSPARI® (sparsentan), the only approved kidney-targeted medicine for IgA nephropathy (IgAN).

Key highlights include:

• Efficacy and safety results of FILSPARI as a first-line treatment in newly diagnosed IgAN patients (SPARTAN Study)
• Analysis of FILSPARI's clinical benefit in IgAN regardless of baseline proteinuria (PROTECT Study)
• Patient-reported outcomes from the PROTECT and DUPLEX Studies
• Data on FILSPARI in combination with SGLT2 inhibitors
• A late-breaking presentation on outcomes in patients with genetic focal segmental glomerulosclerosis (gFSGS) from the DUPLEX Study

The presentations will cover various aspects of FILSPARI's use in IgAN and FSGS, including its efficacy as a first-line treatment and in combination with other therapies.

Travere Therapeutics (Nasdaq: TVTX) has announced a voluntary pause in enrollment for its Phase 3 HARMONY Study of pegtibatinase, a potential treatment for classical homocystinuria (HCU). This decision was made to address necessary process improvements in manufacturing scale-up for commercial production. Currently enrolled patients will continue to receive study medication from unaffected small-scale batches.

The pause was initiated after the company determined that the desired drug substance profile was not achieved in the recent scale-up process. Travere expects to restart enrollment in the HARMONY Study no earlier than 2026. As a result, the company anticipates a reduction in research and development expenses by more than $30 million in 2025 compared to 2024. Travere's cash reserves of $325.4 million as of June 30, 2024, are expected to support operations into 2028.

Travere Therapeutics (NASDAQ: TVTX) announced that on September 10, 2024, its Compensation Committee granted inducement equity grants to six new employees. These grants consist of restricted stock units (RSUs) covering a total of 33,500 shares of common stock. The RSUs were granted outside of Travere's 2018 Equity Incentive Plan but are subject to its terms. They were provided as inducements for new employees joining Travere, in compliance with Nasdaq Listing Rule 5635(c)(4). The RSUs have a four-year vesting schedule, with 25% of the shares vesting annually on the grant date anniversary, contingent on the employee's continued service with Travere.

Travere Therapeutics (NASDAQ: TVTX) has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will present on Tuesday, September 17, 2024, at 9:45 a.m. ET. This event provides an opportunity for investors and interested parties to gain insights into Travere's latest developments and strategies.

A live webcast of the presentation will be available on the Investor page of Travere's website at ir.travere.com/events-presentations. For those unable to attend the live event, a replay will be accessible for up to 30 days following the conference. This allows stakeholders to stay informed about Travere's progress and future plans in the healthcare sector.

Ligand Pharmaceuticals (Nasdaq: LGND) announced that its partner Travere Therapeutics received full FDA approval for FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) at risk of progression. This approval is based on positive long-term results from the PROTECT Study, showing FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.

Key points:

• FILSPARI is the only non-immunosuppressive treatment for IgAN
• Ligand is entitled to a 9% royalty on worldwide net sales of FILSPARI
• FILSPARI demonstrated superior long-term kidney function preservation compared to irbesartan
• The FDA-approved label includes two-year efficacy data

Ligand's CEO, Todd Davis, expressed optimism about FILSPARI's potential as a significant revenue driver for the company in the coming years.

Travere Therapeutics announced FDA full approval of FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) at risk of progression. FILSPARI is the only non-immunosuppressive treatment that significantly slows kidney function decline in IgAN. The approval is based on positive long-term results from the PROTECT Study, showing superior kidney function preservation compared to irbesartan over two years.

Key points:

• FILSPARI is an oral, once-daily medication that targets glomerular injury in the kidney
• It demonstrated a statistically significant treatment effect of 1.2 mL/min/1.73 m2/year in eGFR slope
• The drug showed durable benefits on proteinuria and was well-tolerated
• FILSPARI has the potential to become foundational care in IgAN

Travere Therapeutics (Nasdaq: TVTX) will present two posters on classical homocystinuria (HCU) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) annual symposium in Porto, Portugal, September 3-6, 2024. The presentations will focus on the trial designs of:

• The pivotal Phase 3 HARMONY Study
• ENSEMBLE long-term extension study
• Cohort 7 in the Phase 1/2 COMPOSE Study

All studies involve pegtibatinase, a novel investigational enzyme replacement therapy for HCU. Travere believes pegtibatinase could become the first disease-modifying therapy for classical HCU by effectively replacing the deficient CBS enzyme activity. The posters will be presented on September 4, 2024, from 6:15 – 8:15 p.m. GMT+1 at the Rosa Mota Pavilion.