Fulcrum Therapeutics shares collapsed 50% on June 1 after the FDA forced the company to abandon its lead sickle-cell drug pociredir over cancer-safety concerns.
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Fulcrum Therapeutics plunges 50% after FDA forces pociredir discontinuation
Fulcrum Therapeutics Inc. shares collapsed 50% on June 1 after the FDA forced the company to abandon its lead sickle-cell drug pociredir over cancer-safety concerns.
Truist analyst Gregory Renza said the regulator did not differentiate between sub-units of the PRC2 protein complex, instead viewing the entire complex as carrying a systemic cancer risk.
The decision followed FDA feedback that all drugs targeting the PRC2 complex pose similar malignancy risks, after Ipsen SA's cancer drug Tazverik was withdrawn globally earlier this year. Fulcrum had argued pociredir targets a different component of the complex and had a distinct risk profile, but the FDA rejected that distinction, also citing earlier preclinical malignancy signals.
The company now faces a strategic review that could lead to a sale or merger, with a $25.1 million facility lease now stranded by the program termination. Fulcrum reported $333.3 million in cash and investments as of March 31.
The setback adds to a string of challenges in sickle-cell drug development. Pfizer Inc. withdrew its approved therapy Oxbryta in 2024 and stopped related studies over safety concerns. Pociredir was designed to increase fetal hemoglobin levels by targeting a key sub-unit in the PRC2 protein complex, which normally suppresses its production.
Fulcrum said no new safety concerns had emerged in its clinical trials and that the drug had shown increases in fetal hemoglobin, which can help reduce disease severity in sickle-cell patients. The company has begun cutting costs to preserve cash as it explores strategic alternatives.
The stock's collapse leaves Fulcrum with a market value that may now trade near or below its cash position, making it a potential acquisition target. Investors will watch for any strategic alternative announcement, including a potential sale process, in the coming weeks.
This article is for informational purposes only and does not constitute investment advice.
[1] Fulcrum Therapeutics, Inc. Investigation Initiated: Levi & Korsinsky Investigates the Officers and Directors of Fulcrum Therapeutics, Inc. (FULC)[2] Fulcrum plunges after discontinuing lead program[3] Fulcrum plummets 50% after scrapping lead sickle-cell drug on FDA concerns[4] FULC stock slumps nearly 50% after hours as FDA kills only clinical program over cancer risk
