BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS
Brainstorm Cell Therapeutics Inc. (BCLI)
Last brainstorm cell therapeutics inc. earnings: 11/14 06:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
ir.brainstorm-cell.com
Company Research
Source: PR Newswire
NEW YORK, Feb. 23, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its investigational treatment for amyotrophic lateral sclerosis (ALS).The submission follows an in-person meeting that BrainStorm held with the FDA in December 2023. The interactions leading up to this submission have provided guidance on advancing the planned Phase 3b trial. Participating in an SPA program would allow BrainStorm to reach consensus with the FDA on its clinical trial design, including the proposed statistical analysis, before the study is initiated. This would help ensure that the study would be considered adequate to support a future marketing evaluation. The response is expected within 45 days of submission."Having an SPA in place is an
Show less
Read more
Impact Snapshot
Event Time:
BCLI
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
BCLI 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
BCLI alerts
High impacting Brainstorm Cell Therapeutics Inc. news events
Weekly update
A roundup of the hottest topics
BCLI
News
- BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwn [Yahoo! Finance]Yahoo! Finance
- BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwnPR Newswire
- BrainStorm Cell Therapeutics Regains Compliance with NASDAQ Minimum Market Value Rule [Yahoo! Finance]Yahoo! Finance
- BrainStorm Cell Therapeutics Regains Compliance with NASDAQ Minimum Market Value RulePR Newswire
- BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS [Yahoo! Finance]Yahoo! Finance
BCLI
Earnings
- 11/14/23 - Beat
BCLI
Sec Filings
- 4/25/24 - Form 4
- 4/22/24 - Form 3
- 4/19/24 - Form 4
- BCLI's page on the SEC website