BeyondSpring Announces Positive Pre-NDA Meeting with the U.S. FDA for its Lead Asset, Plinabulin
BeyondSpring, Inc. - Ordinary Shares (BYSI)
Last beyondspring, inc. - ordinary shares earnings: 4/30 07:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
ir.beyondspringpharma.com
Company Research
Source: GlobeNewswire
NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead asset, Plinabulin. The focus of this meeting was the content of the chemistry, manufacturing and control (CMC) sections of the Company’s planned NDAs for Plinabulin for the treatment of non-small cell lung cancer (NSCLC) and chemotherapy-induced neutropenia (CIN) prevention. “We are very pleased with the outcome of this meeting, as we have confirmed our alignment with the FDA regarding expectations for the CMC sections of our planned NDAs for Plinabulin,” said Dr. Lan Huang, CEO and co-founder at BeyondSpring. “We have been working diligently on these submission packages, assembling their regulatory, preclinical, and most recently the clinical components of these indica
Show less
Read more
Impact Snapshot
Event Time:
BYSI
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
BYSI 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
BYSI alerts
High impacting BeyondSpring, Inc. - Ordinary Shares news events
Weekly update
A roundup of the hottest topics
BYSI
News
- BeyondSpring Announces First Patient Dosed with Pembrolizumab, Plinabulin Plus Etoposide/Platinum in a Phase 2 Investigator-initiated Study of First-Line Extensive-Stage Small-Cell Lung Cancer [Yahoo! Finance]Yahoo! Finance
- BeyondSpring Announces First Patient Dosed with Pembrolizumab, Plinabulin Plus Etoposide/Platinum in a Phase 2 Investigator-initiated Study of First-Line Extensive-Stage Small-Cell Lung CancerGlobeNewswire
- Thinking about buying stock in Beyondspring, LAVA Therapeutics, Unicycive Therapeutics, Guardforce AI, or Infobird?PR Newswire
- Retail investors invested in BeyondSpring Inc. (NASDAQ:BYSI) up 125% last week, insiders too were rewarded [Yahoo! Finance]Yahoo! Finance
- BeyondSpring Regains Compliance with Nasdaq Minimum Bid Price and Periodic Filing RequirementsGlobeNewswire
BYSI
Sec Filings
- 3/18/24 - Form 6-K
- 2/26/24 - Form 6-K
- 2/14/24 - Form SC
- BYSI's page on the SEC website