SAN DIEGO - Travere Therapeutics, Inc. (NASDAQ:TVTX) and CSL (OTC:CSLLY) Vifor announced that Swissmedic, the Swiss regulatory authority, has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN). This decision follows the recent approvals by the U.S. Food and Drug Administration in September 2024 and the European Medicines Agency in April 2024.
The authorization in Switzerland is based on the Phase 3 PROTECT Study, which showed statistically significant and clinically meaningful results for FILSPARI. The treatment is designed to target kidney damage directly and is administered orally once a day. It is a non-immunosuppressive option that has been shown to provide superior results compared to maximally dosed irbesartan.
Eric Dube, Ph.D., president and CEO of Travere Therapeutics, expressed the company's readiness to provide access to FILSPARI for the Swiss IgAN community. Emmanuelle Lecomte Brisset, senior vice president and head of global regulatory affairs at CSL, highlighted the high unmet medical need for a targeted therapy to treat IgAN.
IgAN, also known as Berger's disease, is a rare kidney condition where immunoglobulin A builds up in the kidneys, leading to kidney function decline. It is the most common type of primary glomerular disease worldwide and a significant cause of kidney failure.
Travere Therapeutics focuses on identifying, developing, and delivering life-changing therapies for patients with rare diseases. CSL Vifor specializes in iron deficiency and nephrology therapies and is part of CSL, which operates globally.
The safety profile of FILSPARI includes a boxed warning for hepatotoxicity and embryo-fetal toxicity, with a requirement for a Risk Evaluation and Mitigation Strategy (REMS) program for prescribers, patients, and pharmacies.
The information in this article is based on a press release statement from Travere Therapeutics, Inc. and CSL Vifor.
In other recent news, Travere Therapeutics has seen significant developments in its clinical and regulatory journey. The company has reported substantial progress in its Focal Segmental Glomerulosclerosis (FSGS) studies, with potential implications for future study endpoints. Wells Fargo maintains an Equal Weight rating on Travere shares, following the outcomes of the PARASOL workgroup discussions. The company is also readying to reengage with the U.S. Food and Drug Administration (FDA) for potential submissions.
Travere's investigational drug, Sparsentan, has shown promising results in Phase 3 trials, and the company is confident in meeting the proposed benchmarks. Travere's Filspari has received full FDA approval, leading to a 37% sales increase to $27.1 million in a recent quarter. However, the company has temporarily paused patient enrollment for the Phase III HARMONY study of pegtibatinase due to a technical issue during the manufacturing scale-up process.
Several analyst firms, including Stifel, Canaccord Genuity, Citi, H.C. Wainwright, and Barclays, have adjusted their price targets for Travere in light of these developments. Despite the pause in the HARMONY study, the company maintains a robust financial position, with $325.4 million in cash and securities, expected to support its operations into 2028. These are among the recent developments regarding Travere Therapeutics.
InvestingPro Insights
Travere Therapeutics' recent regulatory success with FILSPARI aligns with its strong market performance. According to InvestingPro data, the company has shown impressive growth, with a 201.34% price total return over the past six months and a 147.26% return over the last year. This surge has brought the stock to trade near its 52-week high, with the current price at 97.04% of that peak.
The approval of FILSPARI in Switzerland could contribute to Travere's revenue growth, which is already robust at 47.42% for the last twelve months as of Q2 2024. However, investors should note that despite this growth, the company is not yet profitable, with a negative gross profit margin of -31.44% during the same period.
InvestingPro Tips highlight that while Travere is quickly burning through cash, it operates with a moderate level of debt and its liquid assets exceed short-term obligations. This financial position could be crucial as the company continues to invest in the commercialization of FILSPARI across newly approved markets.
It's worth noting that 3 analysts have revised their earnings upwards for the upcoming period, which may reflect optimism about FILSPARI's market potential. However, analysts do not anticipate the company will be profitable this year, underscoring the ongoing challenges in the biotech sector.
For investors considering Travere Therapeutics, InvestingPro offers 11 additional tips to provide a more comprehensive analysis of the company's financial health and market position.
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