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BrainStorm Cell Therapeutics Inc.

http://www.brainstorm-cell.com

Latest From BrainStorm Cell Therapeutics Inc.

AstraZeneca's Ultomiris Disappoints In ALS, Setting Back Rare Disease Ambitions

AstraZeneca is discontinuing a Phase III trial of the long-acting complement inhibitor it gained via its Alexion acquisition in amyotrophic lateral sclerosis because of lack of efficacy in an interim analysis. Interest is now turning to antisense and cell therapy candidates from other companies that are in late-stage development for the condition.

Clinical Trials Rare Diseases

US FDA Rebukes Another Sponsor For Touting Investigational Product Based On Subgroup Efficacy

CytoDyn’s COVID-19 candidate leronlimab joins BrainStorm’s ALS therapy in being taken to task as FDA has become more willing to publicly counter investigational drug data announcements it considers to be misleading.

Clinical Trials Coronavirus COVID-19

BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.

Drug Approval Standards Clinical Trials

BrainStorm's Cell Therapy Disappoints In Phase III ALS Study

Top-line results from BrainStorm’s NurOwn Phase III ALS study show the cell therapy missed the primary efficacy endpoint, but clinically meaningful responses were seen in a pre-specified subgroup which investigators considered potentially a significant step forward in therapy.

Neurology Clinical Trials
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