Fulcrum Therapeutics, Inc.
A securities class action has been filed in the USDC – N.J. against Fulcrum Therapeutics, Inc. (FULC) (“Fulcrum” or the “Company”) 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 through March 8, 2023.
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.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that:
- the preclinical data submitted in support of FTX-6058 showed safety concerns regarding potential hematological malignancies;
- the foregoing safety concerns increased the likelihood that the FDA would place a clinical hold on preclinical studies of FTX-6058;
- accordingly, the Company had overstated FTX-6058’s clinical and/or commercial prospects; and
- a result, the Company’s public statements were materially false and misleading at all relevant times.
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