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April 17, 2025 News by Lindsey Shapiro, PhD

Brainstorm seeking FDA’s OK to launch NurOwn Phase 3b trial

Brainstorm Cell Therapeutics is moving forward in its efforts to get needed regulatory clearances to launch a Phase 3b clinical trial in the U.S. to test its stem cell therapy NurOwn (debamestrocel) in people with amyotrophic lateral sclerosis (ALS) with less advanced disease. The company has submitted to…

March 7, 2025 News by Michela Luciano, PhD

Tiziana seeking FDA OK to launch clinical trial of foralumab in ALS

Tiziana Life Sciences is seeking regulatory clearance in the U.S. to launch a Phase 2 clinical trial evaluating foralumab nasal spray, its lead therapeutic candidate, as a treatment for amyotrophic lateral sclerosis (ALS). The filing of the company’s investigational new drug application with the U.S. Food and Drug…

September 28, 2022 News by Patricia Inácio, PhD

FDA Clears ALS Clinical Study of Cellenkos Treg Cell Therapy CK0803

Cellenkos will soon launch two Phase 1 clinical trials to investigate the safety and potential efficacy of its regulatory T-cell-based — Treg cell — therapy CK0803 for amyotrophic lateral sclerosis (ALS). The biotech’s announcement follows the approval, by the U.S. Food and Drug Administration (FDA), of its investigational…

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