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Fulcrum Therapeutics Discontinues Sickle Cell Disease Program After US FDA Raises Malignancy Concerns
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Fulcrum Therapeutics Discontinues Sickle Cell Disease Program After US FDA Raises Malignancy Concerns
Jun 1, 2026 2:16 PM

04:56 PM EDT, 06/01/2026 (MT Newswires) -- Fulcrum Therapeutics ( FULC ) has discontinued its pociredir program for sickle cell disease after the US Food and Drug Administration ruled out a viable regulatory path forward for the drug, and launched a review of strategic options, including a potential merger and acquisition, the company said late Monday.

The FDA raised concerns over pociredir's malignancy risk following the global withdrawal of Tazverik, another inhibitor targeting the PRC2 complex, a protein cluster that regulates gene activity, in March due to an unexpectedly high rate of secondary hematologic malignancies, or blood-related cancers, the company said.

Fulcrum had argued that pociredir, which targets a protein called embryonic ectoderm development, carried a different risk profile than Tazverik, which targets a protein called EZH2, but the FDA concluded that any drug targeting the PRC2 complex carries equivalent cancer risk regardless of which specific protein within the complex it blocks, the company said.

Fulcrum said it has initiated steps to reduce operating expenses and preserve capital as part of its review. As of March 31, it had cash, cash equivalents, and marketable securities of $333.3 million.

Shares of the company fell more than 50% in after-hours activity.

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