FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squam...
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
Application Based on Data from Pivotal Phase 3 KEYNOTE-407 Trial KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 3 KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2018. “KEYTRUD
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