Fulcrum Therapeutics discontinued development of its sickle cell disease candidate pociredir after the FDA raised concerns about the benefit-risk profile in an update that included safety signals tied to secondary hematologic malignancies observed with similar mechanism cancer exposures. The FDA conclusion, Fulcrum said, was that targeting the PRC2 complex carries equivalent malignancy risk. The decision triggered a major corporate restructuring: Fulcrum later disclosed plans to cut 85% of staff, leaving 9 full-time employees, and the company said it is seeking strategic alternatives. The move reframes near-term risk posture in a biotech sector increasingly sensitive to target-class safety learnings from oncology programs.
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