BrainStorm Cell Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting ('ADCOM') to discuss the company's Biologics License Application (BLA) for NurOwn®? for the treatment of amyotrophic lateral sclerosis (ALS). Given the goal to proceed to an ADCOM as expeditiously as possible, BrainStorm requested that the Center for Biologics Evaluation and Research (CBER) utilize the FDA's File Over protest procedure and has filed an amendment to the BLA which responds to most of the outstanding questions the FDA has posed.
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5-day change | 1st Jan Change | ||
0.557 USD | +7.09% | +2.63% | +106.01% |
17/04 | Brainstorm Cell Therapeutics Inc. Announces Step Down of Stacy Lindborg as Co-CEO, Effective as of May 9, 2024 | CI |
17/04 | Brainstorm Cell Therapeutics Inc. Announces Management Changes | CI |
EPS Revisions
1st Jan change | Capi. | |
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+106.01% | 3.55Cr | |
+41.22% | 5.09TCr | |
-0.33% | 4.21TCr | |
+49.62% | 4.2TCr | |
-7.20% | 2.92TCr | |
+12.82% | 2.6TCr | |
-21.46% | 1.89TCr | |
+7.54% | 1.32TCr | |
+24.75% | 1.22TCr | |
+30.49% | 1.22TCr |
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- Brainstorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn for the Treatment of ALS