Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis [Yahoo! Finance]
GENFIT S.A. - American Depositary Shares (GNFT)
Company Research
Source: Yahoo! Finance
Approval based on positive Phase III ELATIVE trial data Primary biliary cholangitis impacts approximately 100,000 people in the US and is growing in global prevalence. If inadequately treated, it can cause liver failure U.S. approval of Iqirvo establishes Ipsen as a leader in the treatment of rare cholestatic liver diseases PARIS, FRANCE, 10 June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo ® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo may be prescribed immediately in the U.S. for eligible patients. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not
Show less
Read more
Impact Snapshot
Event Time:
GNFT
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
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
GNFT alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
GNFT alerts
High impacting GENFIT S.A. - American Depositary Shares news events
Weekly update
A roundup of the hottest topics
GNFT
News
- GENFIT: New EASL-EASD-EASO Clinical Practice Guidelines for MASLD Include NIS2+® as Key Tool for Detecting At-Risk MASH [Yahoo! Finance]Yahoo! Finance
- GENFIT: New EASL-EASD-EASO Clinical Practice Guidelines for MASLD Include NIS2+® as Key Tool for Detecting At-Risk MASHGlobeNewswire
- GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo® for Primary Biliary Cholangitis [Yahoo! Finance]Yahoo! Finance
- GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary CholangitisGlobeNewswire
- Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis [Financial Post (Toronto, Ontario, Canada)]Financial Post