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 Inc. (NASDAQ: BCLI) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update [Yahoo! Finance]Yahoo! Finance
- BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate UpdatePR Newswire
- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- BrainStorm Cell Therapeutics and Pluri Partner to Support NurOwn® Phase 3b Trial ManufacturingPR Newswire
BCLI
Earnings
- 11/14/24 - Miss
BCLI
Sec Filings
- 11/14/24 - Form 10-Q
- 11/14/24 - Form 8-K
- 11/14/24 - Form SC
- BCLI's page on the SEC website