Your email has been successfully added to our mailing list.

×
-0.00399652476107739 -0.00747176368375325 -0.0119895742832321 -0.00747176368375325 -0.0286707211120764 -0.0251954821894006 -0.0126846220677672 -0.0248479582971329
Stock impact report

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 Show less Read more
Impact Snapshot
Event Time:
TVTX
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison Updated
Event Day
Stock performance from the time of news release until the following 4pm ET market close
Last price at news event
Since Event
Multi-day stock performance from the time of the news release
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST
PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
Last Price
VWAP
High:
Max Up
High:
Low:
Max Down
Low:
%
Post news range
%
Price change

Price Change Percentage


S&P 500
(SPX)

%

Volume ratio
%

Volume
Ticks

Avg transaction size

Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Opt-in for TVTX alerts
Opt-in for
TVTX alerts

from News Quantified
Opt-in for
TVTX alerts

from News Quantified