Omeros Submits its Biologics License Application to U.S. FDA for Narsoplimab in HSCT-TMA
Omeros Corporation (OMER)
Last omeros corporation earnings: 3/2 04:03 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investor.omeros.com
Company Research
Source: Business Wire
-- Priority Review Requested -- SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.This final portion of the rolling BLA submission, comprised of the BLA’s clinical sections, follows the previously submitted chemistry, manufacturing and controls (CMC) and nonclinical sections, which are under review by FDA. The clinical sections are based on previously reported results of the pivotal trial of narsoplimab in HSCT-TMA in which the drug met its primary endpoint and demonstrated si
Show less
Read more
Impact Snapshot
Event Time:
OMER
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
OMER 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
OMER alerts
High impacting Omeros Corporation news events
Weekly update
A roundup of the hottest topics
OMER
News
- Omeros Co. (NASDAQ: OMER) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Omeros Corporation (NASDAQ:OMER) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results [Yahoo! Finance]Yahoo! Finance
- Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial ResultsBusiness Wire
- Omeros Corporation to Announce Fourth Quarter and Year-End Financial Results on April 1, 2024Business Wire
OMER
Earnings
- 11/9/23 - Beat
OMER
Sec Filings
- 4/1/24 - Form 10-K
- 4/1/24 - Form 8-K
- 3/27/24 - Form SC
- OMER's page on the SEC website