By Mackenzie Tatananni
With no products on the market, Fulcrum Therapeutics was striving to commercialize its experimental drug for sickle cell disease. Those plans have come to a grinding halt.
The Cambridge, Mass.-based biopharmaceutical company said Tuesday that it has discontinued its pociredir program for the treatment of sickle cell disease and launched "a comprehensive review of strategic alternatives to maximize stockholder value."
Shares plunged nearly 49% to $3.30 in the premarket session, on pace for their largest same-day drop since September 2024, according to Dow Jones Market Data. Futures tracking the benchmark S&P 500 were down 0.2%.
On May 28, Fulcrum received meeting minutes from the Food and Drug Administration that raised questions about the drug's risks and benefits. Regulators pointed to "an unexpectedly high rate" of new cancers occurring in patients taking tazemetostat, another investigational therapy that was pulled from the market in March.
Both pociredir and tazemetostat target a protein complex called polycomb repressive complex 2 (PRC2). For pociredir, this triggers the production of a healthy type of hemoglobin, which counteracts the toxic clumping of the protein that occurs in patients with sickle cell disease.
Although Fulcrum argued that pociredir and tazemetostat were mechanistically different, the FDA concluded that any medication targeting the PRC2 protein complex carries the same risk, no matter which part of the complex it attaches to.
The decision "left no viable regulatory path forward for further clinical development of pociredir," Fulcrum said. With its lead asset off the table, the company's long-term survival hangs in the balance.
Left with few alternatives, the company is exploring options including mergers and acquisitions. Fulcrum has also "initiated efforts to significantly reduce its operating expenses and preserve capital," it added.
H.C. Wainwright analyst Andrew Fein conceded that, while the outcome was "disappointing clinically and strategically," especially considering the unmet need in patients with sickle cell disease, it doesn't seal the company's doom.
In fact, "the near-term reality is that Fulcrum is now a cash-rich company entering a strategic review rather than a late-stage SCD development story," Fein said. He noted that Fulcrum ended the first quarter with more than $333 million in cash, cash equivalents, and marketable securities.
Tuesday's news "materially changes our view of Fulcrum because the central pillar of the story was not simply delayed, but effectively removed," Fein continued. Moving forward, he expects its valuation to be tied more strongly to cash, burn reduction, and potential strategic optionality.
Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com
This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.
(END) Dow Jones Newswires
June 02, 2026 07:53 ET (11:53 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.
Comments