Brainstorm Cell Therapeutics Inc.

On November 10, 2022, Brainstorm Cell disclosed that the U.S. Food and Drug Administration (“FDA”) had rejected its New Biologics License Application (“BLA”) for its ALS treatment, NurOwn. On this news, Brainstorm Cell’s stock price fell $1.22, or 42.2%, to close at $1.67 per share on November 10, 2022, thereby injuring investors.

Then, on September 27, 2023, Brainstorm Cell announced the results of the FDA’s review of its resubmitted BLA in which it was determined that there was not substantial evidence to show NurOwn’s effectiveness. Further, the FDA stated that Brainstorm Cell had downplayed the risks associated with NurOwn, and that “the manufacturing information was grossly deficient to ensure adequate product quality.” On this news, Brainstorm Cell’s stock price fell $0.19, or 48.7%, to close at $0.20 per share on September 28, 2023, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Brainstorm Cell downplayed the severity of the FDA’s refusal to file letter; (2) Brainstorm Cell continued to conceal the risks associated with the submission of the BLA; and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.