If you purchased or acquired securities in Brainstorm between August 15, 2022 and September 27, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/BCLI.
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NEW YORK, Nov. 04, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Brainstorm Cell Therapeutics Inc. (“Brainstorm” or the “Company”) (NASDAQ: BCLI) and reminds investors of the January 2, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) Brainstorm Cell downplayed the severity of the Food and Drug Administration’s (“FDA”) refusal to file letter; (2) Brainstorm Cell continued to conceal the risks associated with the submission of the biologics license application (“BLA”); and (3) as a result, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
On September 27, 2023, the U.S. Food and Drug Administration ("FDA") issued a briefing document rejecting Brainstorm Cell's experimental ALS drug. Brainstorm Cell submitted a biologics license application ("BLA") request in August 2022 and received a refusal to file letter from the FDA in November 2022. Despite this, Brainstorm Cell opted for the regulatory procedure of "filing over protest" and still filed the BLA. The briefing document states, "On initial receipt of the BLA, FDA determined that the submission was scientifically incomplete to demonstrate substantial evidence of effectiveness, and that the manufacturing information was grossly deficient to ensure adequate product quality. Examples of critical information not provided in the BLA submission include missing or inadequate control of materials, validation of methods missing or incomplete, lack of data demonstrating manufacturing consistency, control strategy for prefilled syringe not provided, inadequate manufacturing and testing facility information, and facilities not ready for inspection." In addition, the briefing document states, "[i]n addition to the above clinical and statistical concerns, the review team has substantial concerns about product manufacturing. Those issues have yet to be resolved."
On this news, Brainstorm Cell's stock price fell $0.19 per share, or 48.71%, to close at $0.20 per share on September 28, 2023.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding Brainstorm’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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