FDA Accepts Two Applications for Merck’s DIFICID® (fidaxomicin) to Treat Children Aged Six Months Up to 18 years with Clostridium difficile Infections
Merck & Company, Inc. (new) (MRK)
Last merck & company, inc. (new) earnings: 4/28 06:45 am
Check Earnings Report
US:NYSE Investor Relations:
investors.merck.com/home/default.aspx
Company Research
Source: Business Wire
DIFICID® Pediatric Filings Receive Priority Review Classification KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides) difficile infections (CDI) in children aged six months or older. Both applications have received a priority review classification by the FDA. The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020. The investigational pediatric indication for DIFICID was granted Orphan Drug Designation (ODD) in 2010.“Evidence indicates the increasing incidence of C. difficile-associated diarrhea among hospitalized children1,” said Dr. Nicholas Kartsonis, s
Show less
Read more
Impact Snapshot
Event Time:
MRK
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
MRK 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
MRK alerts
High impacting Merck & Company, Inc. (new) news events
Weekly update
A roundup of the hottest topics
MRK
News
- Immutep reports promising efti/Keytruda data for head and neck cancer [Seeking Alpha]Seeking Alpha
- Why Australian Cancer Biotech Firm Immutep Stock Is Soaring On Wednesday? [Yahoo! Finance]Yahoo! Finance
- Oncology Market Expected to Grow at 9.6% CAGR, Reaching USD 533.2 Bn by 2032 | DMR [Yahoo! Finance]Yahoo! Finance
- Vaccines Market Worth $94.9 billion | MarketsandMarkets™ [Yahoo! Finance]Yahoo! Finance
- BioInvent to Present Clinical Data from its Two Leading Assets at ASCO 2024 [Yahoo! Finance]Yahoo! Finance
MRK
Earnings
- 2/1/24 - Beat
MRK
Sec Filings
- 4/11/24 - Form ARS
- 4/11/24 - Form DEFA14A
- 4/11/24 - Form DEF
- MRK's page on the SEC website