FDA

The U.S. Food and Drug Administration (FDA) has agreed on the design of a Phase 3b trial that will test the investigational cell-based therapy NurOwn (debamestrocel) in amyotrophic lateral sclerosis (ALS) patients with less advanced disease. The developer, BrainStorm Cell Therapeutics, plans to launch the trial…

Early data from Phase 2 programs showing that CNM-Au8, an oral therapy candidate for amyotrophic lateral sclerosis (ALS), induced significant reductions in a nerve damage biomarker but did not meet the criteria for accelerated approval at this time, the U.S. Food and Drug Administration (FDA) concluded. Despite the…

BrainStorm Cell Therapeutics is making strategic adjustments — including cuts in its workforce — to accelerate the clinical development of NurOwn as an amyotrophic lateral sclerosis (ALS) treatment. The decision follows the recent withdrawal of its regulatory application with the U.S. Food and Drug Administration…

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…

The U.S. Food and Drug Administration (FDA) has shared its major concerns with data available for NurOwn, BrainStorm Cell Therapeutics‘ experimental stem cell therapy for amyotrophic lateral sclerosis (ALS). According to a new briefing document put out by the FDA, the agency believes that currently…

Changes in neurofilament light chain (NfL) levels — a biomarker of nerve cell damage — were deemed by an advisory committee reasonably likely to predict clinical efficacy from tofersen in people with amyotrophic lateral sclerosis (ALS) caused by SOD1 gene mutations. The unanimous vote from the Peripheral and Central Nervous…

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…

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…