Tag Archive for: NurOwn

In its briefing documents, the agency said it does not believe there is sufficient evidence to support NurOwn’s clinical benefit, adding there were large amounts of missing data.

Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.

The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.

After its Biologics License Application was rejected twice by the FDA, BrainStorm’s Phase III data suggest its amyotrophic lateral sclerosis candidate significantly lowers neurofilament light chain levels.

Nearly two years after the FDA poured cold water on a potential regulatory bid for BrainStorm Cell Therapeutics’ NurOwn, the investigational ALS therapy will get a public hearing. 

BrainStorm Cell Therapeutics concluded 2022 on a cautiously optimistic note as the FDA granted a Type A meeting to discuss the refuse to file letter it served the Israel and New York-based biotech in November for its ALS hopeful, NurOwn. On Wednesday, the company made a series of C-suite moves in what could be a show of confidence in NurOwn’s ability to prevail.

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, 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 (BLA) for NurOwn for the treatment of ALS. The Type A Meeting has been scheduled to occur on January 11, 2023.

BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.

The biopharma world – and markets – spent Thursday evening reacting as the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s AMX0035. 

In what has been a long time coming, Tel Aviv and New York-based BrainStorm announced Monday that it would submit a Biologics License Application (BLA) to the FDA for NurOwn as a potential treatment for ALS. Simultaneously, BrainStorm announced corrected analyses it says strengthen its original conclusions.