SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Fulcrum Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – FULC

NEW YORK, May 27, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Fulcrum Therapeutics, Inc. (“Fulcrum” or the “Company”) (NASDAQ: FULC), and certain officers.   The class action, filed in the United States District Court for the District of New Jersey, and docketed under 23-cv-02360, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Fulcrum securities between March 3, 2022 and March 8, 2023, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased or otherwise acquired Fulcrum securities during the Class Period, you have until June 27, 2023 to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

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 application for FTX-6058 for the potential treatment of sickle-cell disease.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s fda operations, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or 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; (iii) accordingly, the Company had overstated FTX-6058’s clinical and/or commercial prospects; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

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 recent 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.”

On this news, Fulcrum’s stock price fell $1.44, or 23%, to close at $4.82 per share on March 9, 2023.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:

Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980