Fulcrum Therapeutics, Inc.

On February 24, 2023, Fulcrum announced that 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 application for its sickle-cell disease treatment, FTX-6058, due to previously reported preclinical data.

On this news, Fulcrum’s stock price fell $7.23 per share, or 56%, to close at $5.66 per share on February 24, 2023, thereby injuring investors.

Then, on March 9, 2023, before the market opened, Fulcrum released its fourth quarter and full year 2022 financial results, revealing that the previously reported preclinical data referenced by the FDA involved “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.” 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, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the preclinical data submitted in support of FTX-6058 showed safety concerns regarding potential hematological malignancies; (2) the foregoing safety concerns increased the likelihood that the FDA would place a clinical hold on preclinical studies of FTX-6058; (3) accordingly, the Company had overstated FTX-6058’s clinical and/or commercial prospects; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.