BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS
Brainstorm Cell Therapeutics Inc. (BCLI)
Last brainstorm cell therapeutics inc. earnings: 11/14 06:00 am
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Source: PR Newswire
Conference call and webcast at 8:00 a.m. Eastern Time todayNEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS."We are pleased to have reached an agreement with the FDA on key elements of the Phase 3b trial design that provides a potential path forward towards obtaining regulatory approval," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We believe that having t
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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