Fulcrum Therapeutics FULC saw its stock crash 51.1% on Tuesday after announcing the discontinuation of its lead candidate, pociredir, for sickle cell disease (SCD). The decision effectively pushes the company back to the pre-clinical stage, as pociredir was the only asset in its clinical pipeline. Investors reacted sharply to the loss of the program, which had been viewed as FULC’s primary value driver and its most advanced development candidate.
Pociredir is an investigational oral small-molecule EED inhibitor, a component of the PRC2 complex. Earlier clinical data from the phase Ib PIONEER study demonstrated dose-dependent increases in fetal hemoglobin (HbF), broad HbF induction across red blood cells and improvements in markers associated with anemia and hemolysis. The candidate had also received Fast Track and Orphan Drug designations from the FDA for the SCD indication.
FDA Safety Concerns End FULC’s Development of Pociredir
Fulcrum Therapeutics’ decision followed feedback received from the FDA during end-of-phase discussions in May. Per FULC, the regulatory body raised significant concerns regarding the benefit-risk profile of pociredir in SCD after reviewing developments involving Tazverik (tazemetostat), another drug that targets the PRC2 pathway.
Tazverik, an EZH2 inhibitor, was withdrawn globally in March 2026 after reports of an unexpectedly high incidence of secondary hematologic malignancies. Although Fulcrum Therapeutics argued that pociredir targets EED rather than EZH2 and therefore operates through a distinct biological mechanism, the FDA concluded that pharmacological inhibition of any component of the PRC2 complex could potentially carry a similar malignancy risk.
Year to date, FULC stock has plummeted 72.2% compared with the industry’s 2.2% decline.
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The agency’s stance was further influenced by previously disclosed preclinical malignancy findings associated with pociredir. While no new safety signals had emerged in clinical studies and the drug continued to demonstrate encouraging biological activity, the FDA determined that the overall risk profile outweighed the potential benefits in the SCD setting.
As a result, Fulcrum Therapeutics concluded that there was no viable regulatory pathway available for continued clinical development of the candidate. The decision brings an abrupt end to a program that had generated optimism because of its ability to elevate HbF levels, a well-established strategy for reducing disease severity in SCD.
SCD remains an area of significant unmet medical need despite recent treatment advances. The inherited disorder causes abnormal, sickle-shaped red blood cells that can block blood vessels, trigger severe pain episodes, damage organs and reduce life expectancy. Although several therapies are available, many patients continue to face substantial disease burden, underscoring the need for more effective treatment options.
Fulcrum Explores Strategic Alternatives After Setback
With its sole clinical-stage asset discontinued, Fulcrum Therapeutics has initiated a comprehensive review of strategic alternatives aimed at maximizing shareholder value. FULC stated that it will evaluate a range of options, including a merger, acquisition, business combination, or other transactions involving the company or its assets.
At the same time, management has begun implementing measures to significantly reduce operating expenses and preserve cash. As of March 31, 2026, Fulcrum Therapeutics reported cash, cash equivalents and marketable securities totaling $333.3 million. The company has not established a timeline for completing the strategic review and indicated that further updates will be provided only if the board approves a specific course of action or determines that additional disclosure is warranted.
The outcome of this review will likely determine Fulcrum Therapeutics’ future direction, as the company now faces the challenge of rebuilding value without a clinical-stage development program.
Fulcrum Therapeutics, Inc. Price and Consensus
Fulcrum Therapeutics, Inc. price-consensus-chart | Fulcrum Therapeutics, Inc. Quote
FULC’s Zacks Rank & Other Stocks to Consider
Fulcrum Therapeutics currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Liquidia Corporation LQDA, Indivior Pharmaceuticals INDV and Immunocore IMCR, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 59.8% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66IMCR. INDV shares have lost 6.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 2.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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This article originally published on Zacks Investment Research (zacks.com).