Microvast Holdings announces departure of chief financial officer
SAN DIEGO, CA – Travere Therapeutics, Inc. (NASDAQ:TVTX), a biopharmaceutical company with a market capitalization of $1.88 billion, has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for traditional approval of FILSPARI® (sparsentan), a treatment for focal segmental glomerulosclerosis (FSGS), a rare kidney condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for January 13, 2026, and plans to hold an advisory committee meeting to discuss the application.
The sNDA is based on results from the Phase 3 DUPLEX Study and the Phase 2 DUET Study. FILSPARI could potentially become the first FDA-approved medication for FSGS, which is a leading cause of kidney failure and affects over 40,000 patients in the U.S., with a similar prevalence in Europe. According to InvestingPro data, the company’s revenue has grown by 75.65% over the last twelve months, reflecting strong commercial execution. For deeper insights into Travere’s growth metrics and 8 additional key ProTips, consider exploring InvestingPro’s comprehensive analysis.
FSGS is characterized by scarring in the kidneys, leading to a breakdown in the normal filtration of blood, resulting in protein leakage into the urine, a condition known as proteinuria. This proteinuria is believed to contribute to further disease progression. Symptoms of FSGS include swelling in parts of the body (edema), low blood albumin levels, abnormal lipid profiles, and hypertension. Currently, there is no approved pharmacological treatment specifically for FSGS.
The DUPLEX Study is the largest interventional study in FSGS to date, and the only one using a maximally dosed active comparator. Although it did not meet its primary efficacy endpoint over 108 weeks of treatment, it showed significant proteinuria reduction and a lower rate of end-stage kidney disease compared to the control. The DUET Study demonstrated a more than two-fold reduction in proteinuria compared to irbesartan, the active control.
The sNDA submission comes amid the company’s efforts to provide treatment options for rare kidney disorders and follows the successful commercial launch of FILSPARI in IgAN, another rare kidney disease.
Travere Therapeutics, formerly known as Retrophin, Inc., and before that as Desert Gateway, Inc., is a biopharmaceutical company focused on the development of drugs for rare diseases. The company’s shares are traded on The Nasdaq Global Market under the ticker symbol (NASDAQ:TVTX).
This news is based on a press release statement and the company’s recent SEC filing. Investors are advised to consider the inherent risks and uncertainties of the drug approval process and to refer to the company’s SEC filings for a detailed discussion of potential risks.
In other recent news, Travere Therapeutics reported its first-quarter 2025 earnings, surpassing analyst expectations with an earnings per share (EPS) of -$0.19, compared to the forecasted -$0.55. The company also exceeded revenue projections, achieving $81.7 million against the expected $78.05 million. Travere’s flagship product, FILSPARI, contributed significantly to this performance with net sales of $55.9 million, marking a 182% increase compared to the previous year. In a notable development, the U.S. Food and Drug Administration (FDA) accepted Travere Therapeutics’ supplemental New Drug Application for FILSPARI to treat focal segmental glomerulosclerosis (FSGS), with a target action date set for January 13, 2026. The FDA plans to hold an advisory committee meeting to discuss the application. FILSPARI is already approved for slowing kidney function decline in adults with IgA nephropathy (IgAN) and could become the first FDA-approved treatment for FSGS if approved. Additionally, Travere Therapeutics is preparing for potential FDA approval for the new FSGS indication and anticipates continued growth in FILSPARI sales throughout 2025. Analyst firms have shown interest in Travere’s developments, though no specific upgrades or downgrades have been noted in recent reports.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.