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SAN DIEGO - Travere Therapeutics, Inc. (NASDAQ:TVTX), which has seen its stock surge over 163% in the past year and maintains a strong market capitalization of $1.75 billion, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan), potentially the first FDA-approved treatment for focal segmental glomerulosclerosis (FSGS). According to InvestingPro data, the company has demonstrated impressive revenue growth of 60.55% over the last twelve months. The company’s request for priority review is based on findings from the Phase 3 DUPLEX Study and the Phase 2 DUET Study, which showed FILSPARI’s effectiveness in reducing proteinuria and preserving kidney function in FSGS patients.
FSGS is a rare kidney disorder that can lead to kidney failure, affecting over 40,000 people in the U.S. It is marked by scarring of the kidney and proteinuria, where protein leaks into the urine. FILSPARI is an oral medication that targets podocyte injury by blocking specific receptors and is already approved for slowing kidney function decline in adults with IgA nephropathy.
The sNDA submission follows the FDA’s recent decision to remove the requirement for REMS monitoring for embryo-fetal toxicity. Travere plans to request an amendment to the REMS sNDA currently under review for modification of liver monitoring. The FDA has 60 days to decide on the acceptance of the sNDA for review, with an expected notice on the review timeline in the second quarter of 2025. The REMS modification is anticipated to have a Prescription Drug User Fee Act (PDUFA) target action date of August 28, 2025.
The DUPLEX Study, the largest interventional study in FSGS to date, did not meet its primary efficacy endpoint over 108 weeks of treatment but showed significant proteinuria reduction and higher remission rates compared to the active control. While the company currently operates at a loss, InvestingPro analysis reveals a healthy liquidity position with a current ratio of 2.08, indicating strong ability to meet short-term obligations. Subscribers to InvestingPro can access 12 additional key insights about Travere’s financial health and growth prospects. The DUET Study also met its primary efficacy endpoint, with a greater than two-fold reduction in proteinuria compared to irbesartan. Both studies reported a well-tolerated safety profile for FILSPARI.
This announcement is based on a press release statement from Travere Therapeutics. The FDA’s decision on FILSPARI’s approval for FSGS treatment will be a significant milestone for patients suffering from this rare kidney condition, as there are currently no FDA-approved pharmacologic therapies available. With analyst consensus remaining bullish and the next earnings report due on May 1, 2025, investors can access comprehensive analysis and detailed financial metrics through InvestingPro’s exclusive research reports, which provide deep-dive analysis of over 1,400 US stocks.
In other recent news, Travere Therapeutics reported its fourth-quarter 2024 earnings, which exceeded analyst expectations. The company posted an earnings per share (EPS) of -$0.47, surpassing the forecasted -$0.64, and reported revenue of $74.79 million, higher than the anticipated $71.08 million. Net product sales increased 80% year-over-year, driven largely by VILSPARI, which generated $49.6 million in sales during the fourth quarter. Citi analyst Carly Kenselaar maintained a Buy rating on Travere Therapeutics, raising the stock’s price target from $31 to $35. Kenselaar’s optimism is based on anticipated regulatory developments for the company’s drug FILSPARI, including its potential approval for treating FSGS and changes in monitoring requirements for IgAN. Despite the positive earnings report, Travere’s stock fell 10.9% in aftermarket trading. The company continues to prepare for future growth, with plans to submit a supplemental new drug application for FSGS and restart the pegdebatinase Phase III HARMONY study in 2026.
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