BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS [Yahoo! Finance]
Brainstorm Cell Therapeutics Inc. (BCLI)
Last brainstorm cell therapeutics inc. earnings: 11/14 06:00 am
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Source: Yahoo! Finance
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 important next step in advancing our development program for NurOwn," said Chaim Lebovits , President and Chief Executive Officer of Brai
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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