FDA to hold AdCom on BrainStorm's NurOwn as ALS therapy

Shares of USA/Israel-based biotech BrainStorm Cell Therapeutics (Nasdaq: BCLI) rose as much as 13% yesterday on more positive news from the US regulator, which in February issued a refusal-to-file (RTF) letter regarding the submission for its cell therapy NurOwn (autologous MSC-NTF cells).

The US Food and Drug Administration (FDA) said it will hold an advisory committee meeting (AdCom) to discuss the company's Biologics License Application (BLA) for NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). Given the goal to proceed to an AdCom as expeditiously as possible, BrainStorm requested that the Center for Biologics Evaluation and Research (CBER) utilize the FDA's File Over Protest procedure and has filed an amendment to the BLA which responds to most of the outstanding questions the FDA has posed.

ALS community needs additional treatment options