TVTX Stock Falls as FDA Extends Review Timeline for Filspari sNDA [Yahoo! Finance]
Travere Therapeutics, Inc. (TVTX)
Company Research
Source: Yahoo! Finance
supplemental new drug application (sNDA) seeking label expansion for its marketed drug, Filspari (sparsentan), in the focal segmental glomerulosclerosis (FSGS) indication by an additional three months. A final decision from the regulatory body is now expected on April 13, 2026. The extension comes after the company submitted additional information requested by the FDA to better define the clinical benefit of Filspari. The FDA classified these submissions as a major amendment to the sNDA and therefore extended the review timeline from Jan. 13, 2026, to April 13, 2026. The regulatory body, however, did not request any new safety or manufacturing data for Filspari. Filspari is currently approved to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression. In the past six months, shares of Travere Therapeutics have surged 72.1% compared with the industry's increase of 20.4%. Image Source: Zacks Investment Research FSGS is a rar
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TVTX
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
- Travere Therapeutics (NASDAQ:TVTX) had its "buy" rating reaffirmed by analysts at Guggenheim.MarketBeat
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