Fulcrum Therapeutics, Inc. (FULC), a clinical-stage biopharmaceutical company, announced the discontinuation of its lead Pociredir program for the treatment of sickle cell disease (SCD) following FDA's feedback regarding the implications of secondary malignancies observed with Tazverik, another therapy targeting the PRC2 complex like Pociredir, which led to its subsequent global withdrawal. In addition, the firm noted the initiation of a review of strategic alternatives.
Following the news, FULC is plunging 51.25% to $3.13 in the overnight market.
Fulcrum's lead clinical program, Pociredir, is an investigational oral small-molecule EED inhibitor designed to increase fetal haemoglobin expression to treat SCD by modulating the PRC2 complex
On May 28, 2026, Fulcrum received meeting minutes from its FDA end-of-phase interactions, in which the agency expressed concerns regarding Pociredir's benefit-risk profile in SCD, stemming from an unexpectedly high rate of secondary hematologic malignancies observed with Tazverik or tazemetostat, another PRC2 inhibitor, that was withdrawn from the global market in March 2026.
Following that, Fulcrum submitted information to the FDA supporting mechanistic differences between EED (pociredir's target) and EZH2 (tazemetostat's target), which perform different biological roles, relevant to the benefit-risk assessment.
In response, FDA concluded that any pharmacological intervention targeting the PRC2 complex carries an equivalent malignancy risk regardless of the specific subunit engaged, and Pociredir's previously disclosed preclinical malignancy observations have left no potential regulatory path forward for further clinical development.
"We have made the very difficult decision to discontinue development of Pociredir", said Alex C. Sapir, Fulcrum's President and Chief Executive Officer.
Fulcrum said that it will explore potential strategic alternatives, including, but not limited to, a merger, acquisition, business combination, or other strategic transactions involving the company or its assets. As of March 31, 2026, Fulcrum had $333.3 million in cash, cash equivalents, and marketable securities.
The stock closed Monday's trade at $6.42, down 7.23%.
For More Such Biotech Stock News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.