Fulcrum Therapeutics said it discontinued development of its sickle cell disease candidate, pociredir, after FDA concerns about the benefit-risk profile, and moved to a strategic review. The decision triggered a major restructuring, with the company preparing to cut most roles after exiting the lead asset. Separately, reporting tied the FDA’s concerns to unexpectedly high rates of secondary hematologic malignancies observed with tazemetostat (Tazverik), a PRC2 inhibitor withdrawn by Ipsen in March. Fulcrum stated the FDA concluded that any pharmacological intervention targeting the PRC2 complex carries equivalent malignancy risk. Fulcrum indicated it will pursue strategic alternatives as it downsizes, underscoring how safety signals in related PRC2 programs can quickly close regulatory paths for new exposures in non-oncology indications.