BrainStorm Cell Therapeutics Announces Key FDA Meeting for ALS Treatment
BrainStorm Cell Therapeutics Inc., a prominent developer of adult stem cell therapies for neurodegenerative diseases, has announced a significant development in their pursuit of treating amyotrophic lateral sclerosis (ALS). The company has secured an in-person meeting with the U.S. Food & Drug Administration (FDA), scheduled for December 6, 2023. This meeting is a critical step […]
Regenerative Medicine: Induced Pluripotent Stem Cells (iPSCs) Therapy in Neurological Disorder Treatment
In recent years, the scientific community has been abuzz with the potential of induced pluripotent stem cells (iPSCs) for treating a myriad of diseases, especially neurological disorders. The allure of iPSCs lies in their ability to morph into any cell type in the human body, a characteristic termed as pluripotency. This remarkable trait is achieved […]
NeuroSense’s PrimeC Shows Remarkable Impact on ALS Survival Using Innovative iPSC Model
In a groundbreaking study, NeuroSense’s PrimeC has demonstrated a significant effect on the survival rate of induced motor neurons in an innovative in vitro model. This research was conducted in collaboration with the University of Southern California’s Ichida Stem Cell Lab. The study utilized induced pluripotent stem cells (iPSCs) derived from individuals diagnosed with ALS. […]
NurOwn: Revolutionizing ALS Treatment with Biomarkers
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has presented new biomarker data from the Phase 3 trial of its late-stage investigational ALS treatment, NurOwn, at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference. The data showed that treatment with NurOwn significantly elevated markers of […]
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS
NEW YORK, March 27, 2023 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today 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 […]
BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn®
NEW YORK, Dec. 27, 2022 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application […]
I Am ALS and Veterans with ALS send an Open Letter to FDA Requesting an Advisory Committee Meeting to Discuss NurOwn
WASHINGTON, Nov. 23, 2022 /PRNewswire/ — To the Honorable Dr. Robert Califf and Dr. Peter Marks: We represent Veterans with ALS who support Brainstorm Cell Therapeutics’ request for the FDA to hold a public Advisory Committee meeting (“AdCom”) to engage in scientific discourse about the “clinically meaningful” evidence supporting FDA’s approval of a mesenchymal stem cell therapy, NurOwn. When we […]
BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS
NEW YORK, Nov. 10, 2022 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The […]