United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease
Mesoblast Limited - American Depositary Shares (MESO)
US:NASDAQ Investor Relations:
investorsmedia.mesoblast.com
Company Research
Source: GlobeNewswire
NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month. Mesoblast Chief Executive Silviu Itescu said: “We are very pleased to have now been granted both Orphan-Drug Designation and Rare Pediatric Disease Designation by FDA for REVASCOR in the treatment of children with this often-fatal congenital heart condition. The designations were granted on the back of the results from children in a randomized controlled trial indicating that REVASCOR m
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
- Mesoblast Limited (NASDAQ: MESO) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- Mesoblast Limited (NASDAQ: MESO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024 [Yahoo! Finance]Yahoo! Finance
- Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024GlobeNewswire
- Three Leading Growth Companies In Australia With Insider Ownership Reaching 27% [Yahoo! Finance]Yahoo! Finance