Philadelphia, Pennsylvania--(Newsfile Corp. - June 13, 2023) - Berger Montague advises investors that a securities fraud class action lawsuit has been filed against Fulcrum Therapeutics, Inc. ("Fulcrum") (NASDAQ: FULC) on behalf of those who purchased Fulcrum securities between March 3, 2022 and March 8, 2023, both dates inclusive (the "Class Period").
Investor Deadline: Investors who purchased or acquired Fulcrum securities during the Class Period may, no later than June 27, 2023, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation, please contact Berger Montague: James Maro at [email protected] or (267) 637-3176, or Andrew Abramowitz at [email protected] or (215) 875-3015 or visit: https://investigations.bergermontague.com/fulcrum-therapeutics/.
Fulcrum is a clinical-stage biopharmaceutical company. 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 its intention to file an Investigational New Drug ("IND") application for FTX-6058 for the potential treatment of sickle-cell disease ("SCD").
The complaint alleges that, throughout the Class Period, the 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, Fulcrum had overstated FTX-6058's clinical and/or commercial prospects; and (iv) as a result, Fulcrum'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." Following 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 fourth quarter and full year 2022 financial results. The press release provided that in the clinical hold letter Fulcrum 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." Following this news, Fulcrum's stock price fell $1.44, or 23%, to close at $4.82 per share on March 9, 2023.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the Court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
Berger Montague, with offices in Philadelphia, Minneapolis, Washington, D.C., San Diego, San Francisco, Chicago, and Toronto has been a pioneer in securities class action litigation since its founding in 1970. Berger Montague has represented individual and institutional investors for over five decades and serves as lead counsel in courts throughout the United States.
Contacts:
James Maro, Senior Counsel
Berger Montague
(267) 637-3176
[email protected]
Andrew Abramowitz, Senior Counsel
Berger Montague
(215) 875-3015
[email protected]
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/169781
