Fulcrum Therapeutics Inc. (NASDAQ: FULC) announced it will discontinue its pociredir program for sickle cell disease treatment and initiate a strategic review to explore alternatives including potential merger or acquisition.

The Cambridge, Massachusetts-based biopharmaceutical company made the decision following FDA feedback received May 28, 2026, regarding safety concerns with pociredir's benefit-risk profile. The FDA expressed heightened concerns about potential malignancy risks associated with pociredir's inhibition of the PRC2 complex, citing secondary hematologic malignancies observed with Tazverik (tazemetostat), another PRC2 inhibitor that was withdrawn from global markets in March 2026.

Despite Fulcrum's submission of data highlighting mechanistic differences between pociredir's target (EED) and tazemetostat's target (EZH2), the FDA concluded that any pharmacological intervention targeting the PRC2 complex carries equivalent malignancy risk regardless of the specific subunit engaged.

"While no new safety signals have been observed to date with pociredir, the FDA raised concerns regarding the potential malignancy risk associated with pociredir's inhibition of the PRC2 complex," said Alex C. Sapir, Fulcrum's president and chief executive officer.

Pociredir was an investigational oral small-molecule inhibitor designed to increase fetal hemoglobin expression for sickle cell disease treatment. The drug had received Fast Track and Orphan Drug Designation from the FDA and demonstrated dose-dependent increases in fetal hemoglobin in Phase 1b clinical trials.

Fulcrum will explore strategic alternatives including merger, acquisition, business combination, or other transactions involving the company or its assets. The company has initiated efforts to reduce operating expenses and preserve capital but has not set a timeline for completing the strategic review.

As of March 31, 2026, Fulcrum reported $333.3 million in cash, cash equivalents, and marketable securities.