San Diego, CA -- (SBWIRE) -- 05/10/2023 -- The Shareholders Foundation announced that an investor, who purchased shares of Fulcrum Therapeutics, Inc. (NASDAQ: FULC), filed a lawsuit over alleged violations of Federal Securities Laws by Fulcrum Therapeutics, Inc. in connection with certain allegedly false and misleading statements.

Investors who lost money with shares of Fulcrum Therapeutics, Inc. (NASDAQ: FULC) might have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Cambridge, MA based Fulcrum Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on developing the lives of patients with genetically defined diseases in the areas of high unmet medical need in the United States. One of the Company's lead product candidates is FTX-6058, an investigational oral fetal hemoglobin inducer for the treatment of sickle cell disease and other hemoglobinopathies. Over the course of 2022, Fulcrum submitted preclinical data to the U.S. Food and Drug Administration ("FDA") in connection with the Company's intention to file an Investigational New Drug application for FTX-6058 for the potential treatment of sickle-cell disease. On July 17, 2019, Fulcrum Therapeutics, Inc announced the pricing of its initial public offering ("IPO") of 4.5 million shares at $16.00 per share, for gross proceeds of $72.0 million.

On February 24, 2023, Fulcrum Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) verbally informed the company that it has issued a full clinical hold regarding the Investigational New Drug application for its sickle-cell disease treatment, FTX-6058, due to previously reported preclinical data.

Shares of Fulcrum Therapeutics, Inc. (NASDAQ: FULC) declined to as low as $5.17 per share on February 27, 2023.

Then, on March 9, 2023, before the market opened, Fulcrum Therapeutics, Inc announced business highlights and the Company's Q4 and full year 2022 financial results. The press release provided that in the clinical hold letter the Company received on February 24, 2023, the FDA referenced "preclinical data previously submitted in April, October and December 2022, and non-clinical and clinical evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2 (PRC2)," and noted that "the profile of hematological malignancies observed in the non-clinical studies of FTX-6058 is similar to that observed with other inhibitors of PRC2, and that hematological malignancies have been reported clinically with other PRC2 inhibitors." Finally, the FDA requested that Fulcrum "further define the population where the potential benefit of continued treatment with FTX-6058 outweighs potential risk."

Shares of Fulcrum Therapeutics, Inc. (NASDAQ: FULC) declined to as low as $2.25 per share on April 12, 2023.

The plaintiff claims that between March 3, 2022 and March 8, 2023, the Defendants made false and/or misleading statements and/or failed to disclose that the preclinical data submitted in support of FTX-6058 showed safety concerns regarding potential hematological malignancies, that the foregoing safety concerns increased the likelihood that the FDA would place a clinical hold on preclinical studies of FTX-6058, that accordingly, the Company had overstated FTX-6058's clinical and/or commercial prospects, and that as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Fulcrum Therapeutics, Inc. (NASDAQ: FULC) 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.