BrainStorm Cell Therapeutics (BCLI) said Monday the US Food and Drug Administration has authorized the company to launch a phase 3b clinical trial of NurOwn for treating amyotrophic lateral sclerosis.

The study design, including endpoints and statistical methods, was finalized with the FDA under a special protocol assessment, the company said.

The trial will enroll about 200 patients in a randomized, placebo-controlled phase followed by an open-label extension in which all participants receive NurOwn, BrainStorm said.

The primary outcome is the change from baseline at 24 weeks on the ALS Functional Rating Scale-Revised, it added.

BrainStorm also said it is preparing trial sites and seeking additional funding, including non-dilutive grants, to support the launch.

Shares of the company were up over 38% in recent Monday premarket activity.