NurOwn

NurOwn, an experimental treatment, significantly lowered neurofilament light chain (NfL) levels in the spinal fluid, a marker of nerve damage, and this seems to predict slower disease progression in amyotrophic lateral sclerosis (ALS) patients. That’s according to a new analysis of Phase 3 clinical trial (NCT03280056) data…

A final decision by the U.S. Food and Drug Administration (FDA) on whether or not to approve NurOwn for amyotrophic lateral sclerosis (ALS) is now expected no later than Dec. 8. But before that, on Sept. 27, an FDA advisory committee will meet to review the potential benefits…

The U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting to discuss BrainStorm Cell Therapeutics‘ application to approve NurOwn for amyotrophic lateral sclerosis (ALS). Such a meeting, called an ADCOM, is normally for when a therapy is under regulatory review so experts can discuss its…

Difficulties in measuring the progression of amyotrophic lateral sclerosis (ALS) among patients with advanced disease can cause complications in clinical trials, according to a new analysis that highlights how such problems may have affected the failed NurOwn study. The work was led by scientists at BrainStorm…

Biological samples from amyotrophic lateral sclerosis (ALS) patients who took part in the Phase 3 clinical trial of NurOwn, a cell-based therapy, are being donated by BrainStorm Cell Therapeutics to a repository for use by the research community. The samples include blood and spinal fluid (cerebrospinal fluid or CSF)…

The U.S. Food and Drug Administration (FDA) has granted a Type A meeting to BrainStorm Cell Therapeutics to discuss the agency’s refusal to review NurOwn as a treatment for amyotrophic lateral sclerosis (ALS). According to the FDA, type A meetings are used for “an otherwise stalled product development…

BrainStorm Cell Therapeutics has requested a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the agency’s recent refusal to review its application for NurOwn as a treatment for amyotrophic lateral sclerosis (ALS). Type A meetings are scheduled to resolve differences between the…

Veterans with amyotrophic lateral sclerosis (ALS) are calling for the U.S. Food and Drug Administration (FDA) to hold a public advisory committee meeting to discuss the benefits of NurOwn — an investigational cell-based therapy that military service members say has slowed their disease. The request follows the regulatory…

People who took part in clinical testing of NurOwn, a cell therapy for amyotrophic lateral sclerosis (ALS), and family members have sent a letter in support of Brainstorm Cell Therapeutics and its investigational therapy to the U.S. Food and Drug Administration (FDA). They are also asking for an…

The U.S. Food and Drug Administration (FDA) notified Brainstorm Cell Therapeutics that it will not accept for review a company application asking that its cell-based therapy NurOwn be approved as a treatment for amyotrophic lateral sclerosis (ALS). The FDA decision, in the form of a refusal to file…