European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14
Organon & Co. (OGN)
Company Research
Source: Business Wire
SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.1This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240524114174/en/The submissions were based on a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study that aimed to compare the efficacy, safety, tolerability, and immunogenicity
Show less
Read more
Impact Snapshot
Event Time:
OGN
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
OGN 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
OGN alerts
High impacting Organon & Co. news events
Weekly update
A roundup of the hottest topics
OGN
News
- Organon & Co. (OGN) is Attracting Investor Attention: Here is What You Should Know [Yahoo! Finance]Yahoo! Finance
- Organon (OGN) Advances While Market Declines: Some Information for Investors [Yahoo! Finance]Yahoo! Finance
- Organon (OGN) Just Overtook the 20-Day Moving Average [Yahoo! Finance]Yahoo! Finance
- Investors Heavily Search Organon & Co. (OGN): Here is What You Need to Know [Yahoo! Finance]Yahoo! Finance
- Nexstar Media and ASGN have been highlighted as Zacks Bull and Bear of the Day [Yahoo! Finance]Yahoo! Finance
OGN
Earnings
- 5/2/24 - Beat
OGN
Sec Filings
- 6/11/24 - Form 4
- 6/11/24 - Form 4
- 6/11/24 - Form 4
- OGN's page on the SEC website