BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial
Brainstorm Cell Therapeutics Inc. (BCLI)
Last brainstorm cell therapeutics inc. earnings: 11/14 06:00 am
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Source: PR Newswire
NEW YORK, June 26, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm's Phase 3b clinical trial for NurOwn®, its investigational therapy for amyotrophic lateral sclerosis (ALS). This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement for its NurOwn Phase 3b trial. The SPA agreement provided clarity on the design and endpoints of the trial, significantly de-risking the regulatory aspects of the program."This in-person Type C meeting with the FDA was an important step as we finalize preparations for our pivotal Phase 3b trial of NurOwn. We are very pleased with the outcome and are now aligned with the FDA on resolving all
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BCLI
News
- BrainStorm Cell Therapeutics Announces Pricing of $4.0 Million Registered Direct Offering [Yahoo! Finance]Yahoo! Finance
- BrainStorm Cell Therapeutics Announces Pricing of $4.0 Million Registered Direct OfferingPR Newswire
- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial [Yahoo! Finance]Yahoo! Finance
- BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer [Yahoo! Finance]Yahoo! Finance
BCLI
Earnings
- 11/14/23 - Beat
BCLI
Sec Filings
- 6/28/24 - Form 424B5
- 6/28/24 - Form 8-K
- 6/27/24 - Form 424B5
- BCLI's page on the SEC website