Fulcrum scraps SCD program, considers options after FDA takes hard line on safety risks

Fulcrum Therapeutics has scrapped its lead sickle cell disease (SCD) program and is exploring strategic alternatives, including a potential sale, following safety concerns raised by the FDA about possible malignancy risk with its drug pociredir.

Fulcrum’s oral PRC2 inhibitor pociredir was in a Phase 1b study for SCD and had shown strong elevations in fetal hemoglobin, but the FDA concluded that any pharmacologic inhibition of the entire PRC2 complex carried an unacceptable malignancy risk, leaving no viable regulatory path forward.

The FDA’s position was informed by preclinical malignancy observations with pociredir and by the recent withdrawal of Ipsen’s Tazverik (an EZH2 inhibitor) from the U.S. market, which heightened concerns about the entire PRC2‑targeting class of drugs.

Fulcrum’s shares plunged more than 50% on Tuesday June 2, 2026, and the company has initiated a strategic review and begun cost‑cutting measures to preserve cash while evaluating options such as mergers, acquisitions, or an outright sale.