Capricor, the FDA and Millions from the State of California

Stock price of the San Diego firm drops 31 percent on Friday

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A San Diego firm that California’s $12 billion stem cell agency has supported with nearly $18 million has surfaced in the ongoing Trumpian machinations and intrigue at the Food and Drug Administration (FDA).

STAT, the respected national biomedical news service, reported yesterday that FDA disagreements over Capricor, Inc.’s Duchenne therapy and the “management style” of a key FDA official may have led to her ouster.

Capricor is headquartered in San Diego and has received $17.8 million from the California Institute for Regenerative Medicine (CIRM). That includes $3.4 million from CIRM in 2016 for Duchenne research. (A copy of the award contract can be found here.)

In an exclusive story, STAT reported:

“The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has learned.

“The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. But Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research,