Mesoblast Heart Failure Cell Therapy Receives Orphan Drug Designation From FDA for Prevention of Gastrointestinal Bleeding in Patients With Left Ventricular Assist Devices
Mesoblast Limited - American Depositary Shares (MESO)
US:NASDAQ Investor Relations:
investorsmedia.mesoblast.com
Company Research
Source: GlobeNewswire
NEW YORK and MELBOURNE, Australia, June 24, 2019 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq: MESO), global leader in cellular medicines for inflammatory diseases, announced today that the United States Food and Drug Administration (FDA) has granted the company’s product candidate, rexlemestrocel-L, Orphan Drug Designation for prevention of post-implantation mucosal bleeding in end-stage chronic heart failure (CHF) patients who require a left ventricular assist device (LVAD). Mesoblast Chief Executive Dr Silviu Itescu said: “We are very pleased that the FDA has granted our heart failure cell therapy product candidate, Revascor, Orphan Drug designation for use in patients with LVADs to prevent mucosal bleeding, including from the gastrointestinal (GI) tract. We look forward to our upcoming meeting with the FDA to discuss a potential approval pathway under the product’s existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition.
Show less
Read more
Impact Snapshot
Event Time:
MESO
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
MESO 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
MESO alerts
High impacting Mesoblast Limited - American Depositary Shares news events
Weekly update
A roundup of the hottest topics
MESO
News
- Stem Cell Therapy Market Expected To Reach 31.33 Billion, Growing at 11.20% CAGR By 2032 | Introspective Market Research [Yahoo! Finance]Yahoo! Finance
- ASX Growth Companies With High Insider Ownership Seeing Up To 61% Earnings Growth [Yahoo! Finance]Yahoo! Finance
- Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024 [Yahoo! Finance]Yahoo! Finance
- Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024GlobeNewswire
- ASX Growth Companies With High Insider Ownership In October 2024 [Yahoo! Finance]Yahoo! Finance