Fulcrum Therapeutics, Inc. Class Action Lawsuit - FULC
Case Summary
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The Fulcrum Therapeutics class action lawsuit seeks to represent purchasers or acquirers of Fulcrum Therapeutics, Inc. (NASDAQ: FULC) securities between March 3, 2022 and March 8, 2023, inclusive (the “Class Period”). Captioned Celano v. Fulcrum Therapeutics, Inc., No. 23-cv-02360 (D.N.J.), the Fulcrum Therapeutics class action lawsuit charges Fulcrum Therapeutics and certain its top executives with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the Fulcrum Therapeutics class action lawsuit, please provide your information in the form on this page. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Fulcrum Therapeutics class action lawsuit must be filed with the court no later than June 27, 2023.
CASE ALLEGATIONS: One of Fulcrum Therapeutics’ 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 Therapeutics 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.
The Fulcrum Therapeutics class action lawsuit alleges that defendants throughout the Class Period 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; and (iii) accordingly, Fulcrum Therapeutics had overstated FTX-6058’s clinical and/or commercial prospects.
On February 24, 2023, Fulcrum Therapeutics announced that “on February 23, 2023, the [FDA] verbally informed [Fulcrum Therapeutics] that it has issued a full clinical hold regarding the [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 [Fulcrum Therapeutics] within 30 days.” Fulcrum Therapeutics further disclosed that “[t]he clinical hold was initiated by the Agency due to previously reported preclinical data. Fulcrum [Therapeutics] 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 Therapeutics’ stock price fell more than 56%.
Then, on March 9, 2023, Fulcrum Therapeutics announced that in the clinical hold letter it 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 Therapeutics “further define the population where the potential benefit of continued treatment with FTX-6058 outweighs potential risk.” On this news, Fulcrum Therapeutics’ stock price fell 23%, further damaging investors.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Fulcrum Therapeutics securities during the Class Period to seek appointment as lead plaintiff of the Fulcrum Therapeutics class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Fulcrum Therapeutics class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Fulcrum Therapeutics class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Fulcrum Therapeutics class action lawsuit.
ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: Robbins Geller Rudman & Dowd LLP is one of the world’s leading complex class action firms representing plaintiffs in securities fraud cases. The Firm is ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report for recovering more than $1.75 billion for investors in 2022 – the third year in a row Robbins Geller tops the list. And in those three years alone, Robbins Geller recovered nearly $5.3 billion for investors, more than double the amount recovered by any other plaintiffs’ firm. With 200 lawyers in 9 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig.