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Fulcrum Therapeutics, Inc. Lawsuit

Lead Plaintiff Deadline is June 27, 2023

If you purchased or acquired Fulcrum securities between March 3, 2022 and March 8, 2023, please contact Berger Montague using the form below.

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About the Case

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.


Investors who purchased or acquired Fulcrum Therapeutics securities between March 3, 2022 and March 8, 2023, may no later than June 27, 2023, seek to be appointed as a lead plaintiff representative of the class.

lab researcher using test tubes

Berger Montague Counsel

Andrew Abramowitz, Esq.

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aabramowitz@bm.net

(215) 875-3015

bergermontague.com

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James Maro, Esq.

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jmaro@bm.net

(267) 637-3176

bergermontague.com

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