Bullish indicating open at $55-$60, IPO prices at $37
SAN DIEGO - Travere Therapeutics, Inc. (NASDAQ: TVTX) has reached a significant milestone in the potential treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disease, with the U.S. Food and Drug Administration (FDA) accepting its supplemental New Drug Application (sNDA) for FILSPARI (sparsentan). The FDA has scheduled a Prescription Drug User Fee Act (PDUFA) target action date for January 13, 2026, and plans to convene an advisory committee meeting to discuss the application. The company’s stock has shown remarkable strength, delivering a 210% return over the past year, according to InvestingPro data.
FILSPARI, if approved, would be the first FDA-sanctioned treatment specifically for FSGS, which is a leading cause of kidney failure, affecting over 40,000 patients in the U.S. The drug, which is already approved for slowing kidney function decline in adults with IgA nephropathy (IgAN), acts by targeting podocyte injury, a key factor in FSGS progression. With a market capitalization of $1.88 billion and strong revenue growth of 75.65% in the last twelve months, Travere appears well-positioned to capitalize on this opportunity. Get deeper insights into Travere’s financial health and growth potential with a comprehensive Pro Research Report, available exclusively on InvestingPro.
The sNDA is supported by data from the Phase 3 DUPLEX Study and the Phase 2 DUET Study, which demonstrated FILSPARI’s efficacy in reducing proteinuria—a condition where excess protein is excreted in urine and is a common symptom of FSGS—compared with the maximum labeled dose of irbesartan. The safety profile of FILSPARI was comparable to irbesartan, and the drug was well-tolerated in clinical trials.
Eric Dube, Ph.D., president and CEO of Travere Therapeutics, expressed optimism about the potential approval, emphasizing the urgent need for new treatment options for FSGS and the company’s commitment to the FSGS community. The company maintains a healthy financial position with a current ratio of 2.05, indicating strong liquidity to support its development programs. Analysts have set a high target of $47 for the stock, suggesting significant upside potential, though InvestingPro subscribers can access 8 additional key insights about the company’s valuation and prospects.
FSGS is characterized by scarring in the kidneys, leading to a decline in kidney function and, ultimately, kidney failure. Symptoms include proteinuria, swelling in parts of the body (edema), low blood albumin levels, abnormal lipid profiles, and hypertension.
The PARASOL group, a collaborative academic and regulator-led international effort, has underscored the importance of proteinuria reduction in FSGS, associating it with a decreased risk of kidney failure.
The FDA’s decision to review FILSPARI for FSGS represents hope for patients with this condition, and the upcoming advisory committee meeting will be a pivotal step in the drug’s approval process. This information is based on a press release statement from Travere Therapeutics.
In other recent news, Travere Therapeutics reported a strong performance for the first quarter of 2025, surpassing analyst expectations with an earnings per share (EPS) of -$0.19 compared to the projected -$0.55. The company also exceeded revenue forecasts, posting $81.7 million against an expected $78.05 million. Travere’s flagship product, FILSPARI, contributed significantly to this success with net sales of $55.9 million, marking a 182% increase from the previous year. The company is preparing for a potential FDA approval for a new indication of FILSPARI, which could further expand its market presence. Despite the positive earnings, Travere’s stock experienced a slight decline. Analysts from firms like TD Cowen and Guggenheim have shown interest in the company’s ongoing discussions with the FDA regarding new drug indications. Travere anticipates continued growth in FILSPARI sales and expects to receive milestone payments from partnerships throughout the year. The company remains focused on expanding its commercial infrastructure to support future product launches.
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