BrainStorm Cell Therapeutics

BrainStorm Cell Therapeutics is withdrawing the application requesting U.S. approval of its cell-based therapy NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). The decision comes on the heels of a recent U.S. Food and Drug Administration (FDA) advisory committee meeting, in which experts ruled nearly unanimously…

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…

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…

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…

Brainstorm Cell Therapeutics is preparing to file an application with the U.S. Food and Drug Administration (FDA) requesting approval of its cell-based therapy NurOwn for amyotrophic lateral sclerosis (ALS). The decision to submit a biologics license application was based on “the totality of the evidence from NurOwn’s clinical…

Treatment with the cell therapy NurOwn may slow the progression of amyotrophic lateral sclerosis (ALS) for those with a specific variation in the UNC13A gene that is linked with a high risk of the disease. Merit Cudkowicz, MD, chief of neurology at the Massachusetts General Hospital, shared the…

Amyotrophic lateral sclerosis (ALS) patients who completed the expanded access protocol (EAP) for NurOwn may soon be eligible for three additional doses of the cell-based therapy, BrainStorm Cell Therapeutics reported. EAPs, also known as compassionate use programs, are intended to make investigational therapies available outside of a clinical trial…

A significantly greater proportion of amyotrophic lateral sclerosis (ALS) patients with less severe disease showed slower ALS progression with the investigational cell-based therapy NurOwn relative to a placebo. These are the findings of another post-hoc analysis of data from NurOwn’s Phase 3 clinical trial (NCT03280056), further supporting the…