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In a stunning setback for Celgene (CELG), the Food and Drug Administration has refused to review a drug that the biotech has been testing for multiple sclerosis because of “incomplete” pharmacology data. The move is deeply significant: Not only is the medicine the most important product in the Celgene pipeline, but the refusal is the latest in a series of shocks that has unnerved investors over the past few months.

Just last month, for instance, Celgene executives signaled that FDA approval for the drug, called orzanimod, was expected by the end of this year. Last October, the company unexpectedly halted development of another drug for combating Crohn’s disease, and then shortly afterward made deep cuts to its long-term financial guidance, moves that sent its shares plunging.


The FDA refusal sent Celgene stock diving again — shares fell more than 8 percent in midday trading to $87.83. The stock traded at more than $148 last October, before the cascade of bad news began. Now, Wall Street is left speculating about future growth beyond Revlimid, a multiple myeloma medicine that generated $8.1 billion in sales last year, or 63 percent of total Celgene revenue.

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