BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn® Regulatory Pathway for Approval in ALS
Brainstorm Cell Therapeutics Inc. (BCLI)
Last brainstorm cell therapeutics inc. earnings: 11/14 06:00 am
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Source: GlobeNewswire
NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn® regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056). In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed
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BCLI
News
- BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer [Yahoo! Finance]Yahoo! Finance
- BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating OfficerPR Newswire
- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- BCLI: Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation [Yahoo! Finance]Yahoo! Finance
- BCLI: Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness ExpectationPR Newswire
BCLI
Earnings
- 11/14/23 - Beat
BCLI
Sec Filings
- 6/25/24 - Form 3
- 6/25/24 - Form 4
- 6/20/24 - Form 8-K
- BCLI's page on the SEC website