Brainstorm Cell Therapeutics Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of those who acquired Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI) securities during the period from August 15, 2022 through September 27, 2023, inclusive (the “Class Period”). Investors have until January 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
On August 15, 2022, Brainstorm Cell issued a press release announcing its submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for NurOwn, a treatment developed by the Company for amyotrophic lateral sclerosis (“ALS”). The Company’s press release touted the effectiveness of NurOwn.
On September 27, 2023, Brainstorm Cell announced the results of the FDA’s review of its BLA. Members of the Cellular, Tissue, and Gene Therapies Advisory Committee voted 17 to 1 that there was not substantial evidence to show NurOwn’s effectiveness. The FDA briefing document revealed Brainstorm Cell downplayed the risks associated with NurOwn.
That same day, Reuters published an article summarizing the FDA Committee’s decision to vote against Brainstorm Cell’s ALS therapy. On this news, the price of Brainstorm Cell’s shares declined by $0.19, or approximately 48.72%, from $0.39 per share to close at $0.2 on September 28, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) Brainstorm Cell downplayed the severity of the FDA refusal to file letter; and (ii) Brainstorm Cell continued to conceal the risks associated with the submission of the BLA.
On August 15, 2022, Brainstorm Cell issued a press release announcing its submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for NurOwn, a treatment developed by the Company for amyotrophic lateral sclerosis (“ALS”). The Company’s press release touted the effectiveness of NurOwn.
On September 27, 2023, Brainstorm Cell announced the results of the FDA’s review of its BLA. Members of the Cellular, Tissue, and Gene Therapies Advisory Committee voted 17 to 1 that there was not substantial evidence to show NurOwn’s effectiveness. The FDA briefing document revealed Brainstorm Cell downplayed the risks associated with NurOwn.
That same day, Reuters published an article summarizing the FDA Committee’s decision to vote against Brainstorm Cell’s ALS therapy. On this news, the price of Brainstorm Cell’s shares declined by $0.19, or approximately 48.72%, from $0.39 per share to close at $0.2 on September 28, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) Brainstorm Cell downplayed the severity of the FDA refusal to file letter; and (ii) Brainstorm Cell continued to conceal the risks associated with the submission of the BLA.