Fulcrum Therapeutics halted development of its sickle cell disease candidate pociredir after the FDA raised heightened concerns about risks and benefits, the company said. Fulcrum’s decision followed an end-of-phase meeting in which FDA staff referenced an unexpectedly high rate of secondary blood cancers seen with Ipsen’s PRC2 inhibitor tazemetostat (Tazverik). Ipsen subsequently withdrew Tazverik from the market after adverse events surfaced in the Phase Ib/III SYMPHONY-1 trial. Fulcrum said no new safety signals had been observed in pociredir to date, but FDA concluded that any PRC2-targeting intervention carries equivalent malignancy risk regardless of the subunit engaged. Fulcrum also initiated a “comprehensive” strategic review, including exploring a sale or merger and reducing operating expenses.