Travere Therapeutics Extends FILSPARI Review Timeline to April 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: Businesswire
- FDA Review Extension: The FDA has extended the review timeline for Travere Therapeutics' FILSPARI (sparsentan) supplemental New Drug Application for focal segmental glomerulosclerosis (FSGS) to April 13, 2026, indicating the agency's recognition of the drug's potential clinical benefits.
- Clinical Trial Results: The Phase 3 DUPLEX study demonstrated that FILSPARI significantly reduced proteinuria over 108 weeks, although it did not meet the primary efficacy endpoint, providing clinically meaningful benefits that may offer new hope for FSGS patients.
- Market Potential: If approved, FILSPARI would be the first medication indicated for FSGS, addressing the urgent needs of over 40,000 patients in the U.S., marking a significant breakthrough for Travere in the rare disease space.
- Ongoing Commercial Preparations: Travere Therapeutics continues its commercial preparations during the FDA review period to ensure a successful launch of FILSPARI if approved, demonstrating the company's strong commitment to meeting patient needs.
Analyst Views on TVTX
Wall Street analysts forecast TVTX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for TVTX is 40.09 USD with a low forecast of 31.00 USD and a high forecast of 49.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
14 Analyst Rating
12 Buy
2 Hold
0 Sell
Strong Buy
Current: 34.100
Low
31.00
Averages
40.09
High
49.00
Current: 34.100
Low
31.00
Averages
40.09
High
49.00
About TVTX
Travere Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on identifying, developing, and delivering life-changing therapies to people living with rare kidney and metabolic diseases. Its product, FILSPARI (sparsentan), is indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. FILSPARI is an oral, once-daily, non-immunosuppressive medication that directly targets glomerular injury in the kidney. Sparsentan is also in late-stage development for focal segmental glomerulosclerosis (FSGS). The Company’s Pegtibatinase is a novel investigational human enzyme replacement candidate being evaluated for the treatment of classical homocystinuria (HCU), which is a rare metabolic disorder. Its commercial products, Thiola and Thiola EC, are for the treatment of cystinuria, a rare genetic cystine transport disorder that causes high cystine levels in the urine and the formation of recurring kidney stones.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
