United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD) [...
Mesoblast Limited - American Depositary Shares (MESO)
US:NASDAQ Investor Relations:
investorsmedia.mesoblast.com
Company Research
Source: Yahoo! Finance
FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast's allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor ® ) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation. “We are very pleased with FDA's feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu. “We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.” Every year in the United States over 100,000 patients progress to end-stage HFrEF. In these patient
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
- Three Leading Growth Companies In Australia With Insider Ownership Reaching 27% [Yahoo! Finance]Yahoo! Finance
- Degenerative Disc Disease Market Forecast - 2032; NSAIDs, Opioids, and others are major revenue generators [Yahoo! Finance]Yahoo! Finance
- Degenerative Disc Disease Drug Pipeline Research Report 2024 Featuring Spine BioPharma, Angitia Biopharmaceuticals, Mesoblast, BioRestorative Therapies, and DiscGenics, Inc. [Yahoo! Finance]Yahoo! Finance
- Mesoblast Limited: Back From The Dead [Seeking Alpha]Seeking Alpha
- Mesoblast Limited (NASDAQ: MESO) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat