Travere Therapeutics Announces FDA Extends Review of sNDA for FILSPARI® (sparsentan) in FSGS
Travere Therapeutics, Inc. (TVTX)
Company Research
Source: Business Wire
New PDUFA target action date is April 13, 2026Commercial launch preparations continue in anticipation of potential approval SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that today the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026.The extension follows the recent submission of responses requested by the FDA to further characterize the clinical benefit of FILSPARI. The FDA determined that the additional responses constituted a Major Amendment (MA) to the sNDA and extended the action date accordingly. No additional information relating to the safety or manufacturing of FILSPARI has been requested.“We believe in the potential of FILSPARI to make a meaningful difference in the lives of people living with FSGS and are encour
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News
- TVTX INVESTIGATION ALERT: Robbins Geller Rudman & Dowd LLP Launches Investigation into Travere Therapeutics, Inc., and Encourages Investors and Potential Witnesses to Contact Law FirmBusiness Wire
- Travere Therapeutics 2026 Outlook: Filspari Momentum, FSGS FDA Delay, And Market Potential [Seeking Alpha]Seeking Alpha
- Is Travere Therapeutics (TVTX) Pricing Reflect Long Term Value After Recent Share Price Pullback [Yahoo! Finance]Yahoo! Finance
- INVESTOR ALERT: Investigation of Travere Therapeutics, Inc. (TVTX) by Holzer & Holzer, LLCGlobeNewswire
- TVTX Stock Falls as FDA Extends Review Timeline for Filspari sNDA [Yahoo! Finance]Yahoo! Finance
TVTX
Earnings
- 10/30/25 - Beat
TVTX
Sec Filings
- 1/13/26 - Form 8-K
- 1/12/26 - Form 8-K
- 1/8/26 - Form SCHEDULE
- TVTX's page on the SEC website