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.
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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.