Amarin Announces FDA Notification of Advisory Committee Meeting Planned to be Held in November 2019 in Connection With Vascepa® REDUCE-IT™ sNDA
Last amarin corp plc ads earnings: 4/30 05:00 am
Check Earnings Report
US:NASDAQ Investor Relations: investor.amarincorp.com/investors
PDUFA Date Extension to End of December 2019 Expected Management to Host Conference Call Today at 7:00 p.m. ET BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that it received notice today from the U.S. Food and Drug Administration (FDA) that the FDA plans to hold an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa® (icosapent ethyl) labeling based on the REDUCE-IT™ cardiovascular outcomes study. Before this communication, the FDA had been silent as to whether it would convene an AdCom in connection with its review of the REDUCE-IT sNDA. The FDA expressed, based on the timing of its recent decision to convene an AdCom, that November 14th is the earliest date on which it could hold an AdCom due t
[Read more]

Impact snapshot | Event time: | AMRN | ||||
---|---|---|---|---|---|---|
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
AMRN alerts
AMRN alerts
from News Quantified
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
AMRN alerts
High impacting Amarin Corp Plc ADS news events
Weekly update
A roundup of the hottest topics
AMRN
News
- Amarin Commences Commercial Initiatives for VAZKEPA in European Union Following Recent Regulatory Approval for Cardiovascular Risk Reduction IndicationGlobeNewswire
- UPDATE 1-European Commission clears Amarin's fish-oil derived heart drug Vazkepa [Reuters]Reuters
- Amarin Receives European Commission (EC) Approval for VAZKEPA to Reduce Cardiovascular RiskGlobeNewswire
- Fifteen Medical Societies Now Recommend Icosapent Ethyl to Reduce Cardiovascular Risk, Further Supporting that VASCEPA® is Rapidly Becoming a New Standard of CareGlobeNewswire
- VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021GlobeNewswire
- More
AMRN
SEC Filings
- 4/2/21 - Form 4
- 4/2/21 - Form 4
- 4/2/21 - Form 4
- AMRN's page on the SEC website
- More