A securities class action has been filed against Fulcrum Therapeutics, Inc. (FULC) 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.  This case has been filed in the USDC – NJ.

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.