A letter from the FDA, dated June 12, indicates that the agency filed a request to withdraw from publication the notice concerning the “Cellular, Tissue and Gene Therapies Advisory Committee: Notice of Meeting” for the BLA from Capricor for deramiocel, which is currently on public inspection and scheduled to publish in the Federal Register on June 13. “FDA requires additional time regarding this notice prior to publication,” the letter from the FDA stated. In morning trading as the letter gets circulated among traders, shares of Capricor Therapeutics (CAPR) have fallen 8.25%, or $1.15, to $12.79.
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