Did you lose money on investments in Fulcrum Therapeutics, Inc.? If so, please visit Fulcrum Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or firstname.lastname@example.org to discuss your rights.
NEW YORK, May 03, 2023 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Fulcrum Therapeutics, Inc. (“Fulcrum” or the “Company”) (NASDAQ: FULC) between March 3, 2022 and March 8, 2023, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the District of New Jersey and alleges violations of the Securities Exchange Act of 1934.
Fulcrum is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. 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 (“IND”) application for FTX-6058 for the potential treatment of sickle-cell disease (“SCD”).
Plaintiff alleges that Defendants made materially false and misleading statements throughout the Class Period. Specifically, Plaintiff alleges that Defendants failed to disclose that: (i) the preclinical data submitted in support of FTX-6058 showed safety concerns regarding potential hematological malignancies; (ii) the foregoing safety concerns increased the likelihood that the FDA would place a clinical hold on preclinical studies of FTX-6058; and (iii) accordingly, the Company had overstated FTX-6058’s clinical and/or commercial prospects.
On February 24, 2023, Fulcrum issued a press release “announc[ing] that on February 23, 2023, 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 (IND) application for FTX-6058 for the potential treatment of sickle-cell disease. The Agency indicated that it would provide a formal Clinical Hold Letter to the company within 30 days.” Fulcrum further disclosed that “[t]he clinical hold was initiated by the Agency due to previously reported preclinical data. Fulcrum will suspend dosing in the Phase 1b trial of FTX-6058 and intends to work diligently with the Agency to resolve the hold as soon as possible.”
On this news, Fulcrum’s stock price fell $7.23 per share, or 56.09%, to close at $5.66 per share on February 24, 2023.
Then, on March 9, 2023, before the market opened, Fulcrum issued a press release announcing the Company’s Q4 and full year 2022 financial results. The press release stated 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).” The release also 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.” Fulcrum also revealed that the FDA had requested that the Company “further define the population where the potential benefit of continued treatment with FTX-6058 outweighs potential risk.”
On this news, Fulcrum’s stock price fell $1.44, or 23%, to close at $4.82 per share on March 9, 2023.
If you wish to serve as lead plaintiff, you must move the Court no later than June 27, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
If you purchased or acquired Fulcrum securities, and/or would like to discuss your legal rights and options please visit Fulcrum Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or email@example.com.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
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