Should You Throw in the Towel on Intercept Pharmaceuticals After Its Big Setback? [The Motley Fool]
Intercept Pharmaceuticals, Inc. (ICPT)
Last intercept pharmaceuticals, inc. earnings: 2/25 07:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
ir.interceptpharma.com/investor-relations
Company Research
Source: The Motley Fool
Intercept Pharmaceuticals(NASDAQ:ICPTThat launch won't happen anytime soon. On Monday, Intercept announced that it hadreceived a complete response letter (CRL) from the FDAImage source: Getty Images.What we know about the bad newsThe FDA doesn't release CRLs to the public, so we don't know for sure everything that was in it. However, Intercept basically stated that the agency found that the benefit of OCA doesn't outweigh the potential risks. That's a surefire recipe for an FDA rejection.But there's more to the story. Intercept's filing for OCA was for an accelerated approval, based on positive interim analysis results from the late-stage Regenerate study. With accelerated approvals, the FDA allows a surrogate endpoint to be used for faster approval.Intercept said that the FDA believes that "the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain." This surrogate endpoint measured the change in liver tissues caused by NASH.What about the potential
Show less
Read more
Impact Snapshot
Event Time:
ICPT
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
ICPT 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
ICPT alerts
High impacting Intercept Pharmaceuticals, Inc. news events
Weekly update
A roundup of the hottest topics