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The California Stem Cell Report
FDA Nixes Capricor Rare Disease Treatment, Stock Plummets

FDA Nixes Capricor Rare Disease Treatment, Stock Plummets

San Diego firm hopes to overturn decision, no comment from CIRM, which backed therapy with millions.

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David Jensen
Jul 11, 2025
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The California Stem Cell Report
FDA Nixes Capricor Rare Disease Treatment, Stock Plummets
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The Food and Drug Administration (FDA) has rejected a San Diego firm’s treatment for a rare muscular disorder that leads to early death, sending the company’s stock price 30 percent lower this morning and delivering a blow to California’s $12 billion stem cell research program.

The FDA said there was insufficient evidence to justify approvi…

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