An investigation for investors in Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) shares over potential securities laws violations by Brainstorm Cell Therapeutics Inc. was announced.
San Diego, CA -- (SBWIRE) -- 10/23/2023 -- Brainstorm Cell Therapeutics Inc. is under investigation over potential securities laws violations.
Investors who purchased shares of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
The investigation by a law firm focuses on whether a series of statements by Brainstorm Cell Therapeutics Inc. regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
New York based Brainstorm Cell Therapeutics Inc., a biotechnology company, engages in the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases.
On September 27, 2023, the U.S. Food and Drug Administration ("FDA") issued a briefing document rejecting Brainstorm Cell Therapeutics' experimental ALS drug. rainstorm Cell Therapeutics Inc 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 Therapeutics Inc 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."
Shares of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) declined from $3.29 per share in May 2023 to as low as $0.14 per share on October 11, 2023.
Those who purchased shares of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
About The Shareholders Foundation
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.